Cruxi
Recorded device evidence
The acquired K122071 file contains product-specific indications and users, design and operating principle, performance evidence actually described, clinical evidence or its stated absence 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 2026-10-08. Source versions and topic-specific limits are listed below.
Computed exact-code research
The 2021–2025 complete-year cohort contains 28 selected decisions under primary code FLE. 28 have valid reported receipt/decision pairs; 0 pairs are missing or invalid.
Calendar elapsed days: lower quartile 92.5, median 136.0, upper quartile 212.2. These are recorded calendar differences, not active FDA review time.
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 |
|---|---|---|---|---|
| K122071 ↗ · this page | GETINGE 400HC-E / SERIES STEAM STERILIZER | 2012-07-16 → 2013-03-12 | 239 | Traditional |
| K261055 ↗ | AMSCO 700 Steam Sterilizer | 2026-03-31 → 2026-06-24 | 85 | Traditional |
| K260254 ↗ | Enbio PRO | 2026-01-27 → 2026-02-26 | 30 | Traditional |
| K252307 ↗ | Getinge GSS67N Series Steam Sterilizer | 2025-07-24 → 2026-01-22 | 182 | Traditional |
| K250168 ↗ | Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer | 2025-01-21 → 2025-12-30 | 343 | Traditional |
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.
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; 0 parent records excluded; units record counts; calendar elapsed days.
Source snapshots: 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002.
Read beyond the decision row
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.
K122071 · PDF page 4 ↗ Source 2
Read this statement in the original PDF; no complete statement fits the short excerpt.
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.
K122071 · PDF page 1 ↗ Source 3
The Getinge 400HC-EI500HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities.
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.
K122071 · PDF page 5 ↗ Source 4
Factory recommended cycles were tested per industry standards and guidelines and effectiveness of sterilizer function was demonstrated by complete kill of biological indicators.
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.
K122071 · PDF page 6 ↗ Source 5
No clinical data is required for this device classification submission.
Compare with your product: Preserve whether the summary describes clinical evidence or says none was performed. This recorded case does not determine whether your product needs clinical evidence.
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: {}.
Known context: US. Confirm the organisation’s role, relevant activities and markets against the cited criteria.
| Source fact | Recorded value | What to check |
|---|---|---|
| 510(k) identifier | K122071 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Generic device category | GETINGE 400HC-E / SERIES STEAM STERILIZER [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Recorded applicant | Getinge Sourcing, LLC [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| FDA product code | FLE [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Decision date | 2013-03-12 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Recorded decision code | SESE [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Submission type | Traditional [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
| Receipt date | 2012-07-16 [1] | Dated official record fact; not proof of current commercial availability or applicability to another device. |
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
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.
Useful evidence: Our proposed indication, user/population and use environment beside this exact recorded indication.
Compare physical design, materials, energy, accessories and operating principle with your design. Ask which documented differences change the evidence scope.
Useful evidence: Design description, materials/components, accessory list and a differences matrix.
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.
Useful evidence: The cited narrative and full tables, underlying protocols/results and a reviewed comparison with the proposed product.
Preserve whether the summary describes clinical evidence or says none was performed. This recorded case does not determine whether your product needs clinical evidence.
Useful evidence: Your proposed claims and supporting evidence, plus a reviewed rationale for clinical-evidence needs.
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
2026-10-05 · retrieved 2026-10-06
Source key D01 · snapshot 5a86994ba49a37e71e09be96803fd51981c6c43eaa96caab41aea2b188bfe002
Thu, 11 Apr 2013 16:52:37 GMT · retrieved 2026-10-08
Source key D02 · snapshot cacb894c59baa450aba137be7e3cceaad41c218f274c82f36cea5fa73f360c38
Confirm the facts, scope and contact preference before sharing your project. Preparing this page sends no provider outreach.