The acquired K203362 file contains product-specific indications and users, design and operating principle, non-clinical evidence actually described, performance evidence actually described sections. Compare these dated manufacturer statements with your own indication and design before commissioning evidence work. They describe this submission; they do not prescribe your testing, validate performance independently or establish a suitable predicate.
Evidence retrieved 2026-10-07. Source versions and topic-specific limits are listed below.
Computed exact-code research
This decision beside its recorded product-code cohort
The 2021–2025 complete-year cohort contains 3 selected decisions under primary code JOH. 3 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
No quartiles are displayed: this complete-year cohort has fewer than 20 valid pairs.
The table shows the named decision and up to four latest exact-code research records through 2026-09-27. It can include partial-year records outside the complete-year cohort. The quartiles above use the full stated cohort, not this displayed selection.
| Research record | Recorded device | Receipt → decision | Calendar elapsed days | Recorded submission type |
|---|
| K203362 ↗ · this page | TRACOE vario | 2020-11-16 → 2021-08-05 | 262 | Traditional |
|---|
| K251313 ↗ | Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Distal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT with TaperGuard Cuff, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley Adult Flexible Disposable Inner Cannula XLT | 2025-04-28 → 2025-12-29 | 245 | Traditional |
|---|
| K210833 ↗ | Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula | 2021-03-19 → 2021-11-26 | 252 | Traditional |
|---|
| K193077 ↗ | Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff | 2019-11-05 → 2020-06-01 | 209 | Traditional |
|---|
| K193133 ↗ | Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set | 2019-11-12 → 2019-12-12 | 30 | Special |
|---|
Use this comparison: select a record to investigate, read its actual indications and design, and document differences. A shared code or elapsed period cannot establish its relevance to your device.
Calendar elapsed days are not active FDA review time, a promised schedule or a success probability. The selection includes only the stated recorded decisions, not all applications. Latest records can postdate the named historical decision and are contextual research, not its predicates. Shared codes, summaries and observed records do not prove equivalence, current market availability, buyer applicability or predicate suitability.
Calculation, selection and source versions
Reuse the complete-endpoint exact-primary-code, documented SE-decision cohort and its stated cutoff/window. Retain its type-7 quartiles only when at least 20 valid date pairs are present. Independently subtract the named official record’s receipt date from its decision date; missing or negative pairs remain unknown. Show up to four latest exact-code research records, excluding the named ID. Parent analysis hash, source snapshots and calculation versions are retained.
Calculation: fda-named-decision-cohort-context-1; cutoff 2026-09-27; 1 parent records excluded; units record counts; calendar elapsed days.
Source snapshots: 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002.
Read beyond the decision row
Recorded evidence and differences to investigate
The summary is manufacturer-submitted context hosted by FDA. Negative/no-study statements are preserved. Evidence themes are not binding legal requirements.
Short opening excerpts identify the source sections. Read the linked original for the full study context, negative statements, tables and limitations. Public quotations are limited to 120 words per acquired summary; the internal evidence packet retains exact section ranges for review.
Indications and users
K203362 · PDF page 5 ↗ Source 2
TRACOE® vario Tracheostomy Tubes are indicated for providing tracheal access for airway management
especially to those patients with unusual anatomy or patients with thick necks.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare the recorded indication, population, body site and use environment with your proposed label. Record each change instead of assuming the primary code settles intended use.
Design and operating principle
K203362 · PDF page 4 ↗ Source 3
TRACOE® vario Tracheostomy Tubes are suitable for adults and adolescents (12-21 years) where access
to the airway via a tracheostoma is required.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Non-clinical evidence actually described
K203362 · PDF page 7 ↗ Source 4
Functionality testing of the TRACOE® vario Tracheostomy Tubes was performed in
accordance ISO 5366, and ISO 5356-1.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: Treat these as documented evidence themes in this case, including any limitations or negative statements. Ask which protocols, design inputs and acceptance rationale would be justified for your product; these excerpts are not a mandatory test panel.
Performance evidence actually described
K203362 · PDF page 7 ↗ Source 4
The TRACOE® vario Tracheostomy Tubes, including the Minimally Traumatic
Insertion System, are the same in material, processing, and functionality as TRACOE legally US marketed
devices.
The excerpt is shortened at a complete statement. Read the complete section in the original PDF before interpreting the evidence.
Compare with your product: The source labels this section as performance data. Determine which described evidence is bench, software, biological or clinical from the actual narrative and original tables; the section label alone does not settle that distinction or prescribe your testing.
Extraction selection and limits
Select observed whole-line section headings or explicit colon-delimited inline labels on readable PDF pages, including the explicitly documented heading-spacing variants in this parser version. Preserve the original heading, character ranges and layout; do not repair excerpt text. Exclude letter boilerplate and uncertain pages. Stop at observed table headings; do not infer table columns or scalar results from layout text. Multi-column or suspicious split-numeric excerpts are excluded until reviewed alternate extraction is available. Original layout records remain retained; any alternate text has its own extractor-version locator and requires original-page review. For each dimension, prefer usable versioned alternate text where available, selecting its longest usable excerpt; otherwise select the longest usable original-layout excerpt. Ties preserve source order. Bounded to 64 PDF pages and 3,500 characters per section. This is a selection, not a complete dossier analysis.
Excluded extraction items: {'uncertain_pdf_page': 1}.
Historical references beside dated FDA recognition metadata
Read each mention in the linked original summary, including statements that testing was not performed. Recognition metadata does not determine your testing needs, chosen edition or transition eligibility.
| Reference in this historical summary | Designation in the acquired FDA export | Recognition / entry date | Recorded transition-expiration date | Sources |
|---|
ISO 5366
Bench Testing | ISO 5366 First edition 2016-10-01
Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors | 1-117 · Complete
01/14/2019 | Not recorded in this export row | Summary [4] · Metadata [5]
Read scope and recognition limits ↗ |
ISO 5356-1
Bench Testing | ISO 5356-1 Third edition 2004-05-15
Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets | 1-62 · Complete
03/16/2012 | Not recorded in this export row | Summary [4] · Metadata [6]
Read scope and recognition limits ↗ |
ISO 5356-1
Bench Testing | ANSI AAMI ISO 5356-1:2004
Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets | 1-62 · Complete
03/16/2012 | Not recorded in this export row | Summary [4] · Metadata [7]
Read scope and recognition limits ↗ |
ISO 15223-1
Bench Testing | ISO 15223-1 Fourth edition 2021-07 [Including AMD1: 2025]
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements [Including Amendment 1 (2025)] | 5-148 · Complete
12/22/2025 | Not recorded in this export row | Summary [4] · Metadata [8]
Read scope and recognition limits ↗ |
ISO 15223-1
Bench Testing | ISO 15223-1 Fourth edition 2021-07
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements | 5-134 · Complete
12/20/2021 | 12/17/2028 | Summary [4] · Metadata [9]
Read scope and recognition limits ↗ |
Prepare for your provider: the proposed protocol/report edition, its justification for your device and the complete current FDA recognition sheet. In particular, inspect exclusions for partial recognition. An edition difference does not automatically make the historical evidence unusable.
Identifier-matching method and selection limits
Match explicit ISO/IEC identifiers in selected preserved summary excerpts to the acquired, count-reconciled FDA metadata export. Preserve the historical edition mention, current snapshot designations, entry dates, recognition extent and any recorded transition-expiration date as separate facts. No title-similarity, edition-equivalence, test-mandate or transition-eligibility inference. At most twenty matched occurrences and thirty metadata rows per reference; wide matches are held for separate review.
4 of 4 matched reference occurrences shown.
