The acquired K150573 file contains product-specific indications and users, recorded comparison and differences, 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.
Source limits that change the comparison
The recorded change concerns a distal balloon bond
The manufacturer describes changing the uterine balloon distal-end bond from a heat bond to a UV bond to reduce the potential for leaks. That specific design change needs comparison; the statement that the devices have the same technological characteristics does not replace it. [2]
Prepare or ask: Compare bond design, materials, manufacturing controls, leak/strength evidence and worst-case conditions for the proposed modification. This record does not prescribe a universal test or guarantee performance.
Dated manufacturer-submitted summary; current buyer applicability remains unresolved. PDF page 4 ↗
The bleeding-control indication has a conservative-management limit
The dated indication describes temporary control or reduction of postpartum uterine bleeding, with vaginal balloon anchoring and tamponade when vaginal bleeding is present. It limits use to postpartum uterine bleeding when conservative management is warranted. [2]
Prepare or ask: Compare the proposed setting, bleeding-control role and label; keep this reference indication separate from a clinical recommendation for an individual patient.
Dated manufacturer-submitted summary; current buyer applicability remains unresolved. PDF page 4 ↗
Duration and supplied-state facts belong with the bond change
The description permits retention for up to 24 hours and describes sterile, one-time use for one patient. The same passage limits the design change to the distal uterine-balloon bond. These are recorded reference facts, not validated conditions for the buyer’s product. [3]
Prepare or ask: Compare intended retention, single-use/supplied-state labeling and bond change together; ask which design-specific evidence supports differences.
Dated manufacturer-submitted summary; current buyer applicability remains unresolved. PDF page 5 ↗
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 OQY. 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 |
|---|
| K150573 ↗ · this page | ebb Complete Tamponade System | 2015-03-06 → 2015-03-25 | 19 | Special |
|---|
| K253642 ↗ | Jada System (Jada-2002) | 2025-11-19 → 2026-05-15 | 177 | Traditional |
|---|
| K230849 ↗ | ELLAVI UBT | 2023-03-28 → 2023-11-13 | 230 | Traditional |
|---|
| K223098 ↗ | Bakri Essential Postpartum Balloon | 2022-09-30 → 2022-10-28 | 28 | Special |
|---|
| K212757 ↗ | Jada System | 2021-08-31 → 2021-09-30 | 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; 0 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
K150573 · PDF page 4 ↗ Source 2
The ebb Complete Tamponade System is indicated for use in providing temporary control or
reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine
Balloon and provides vaginal tamponade if vaginal bleeding is present.
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.
Recorded comparison and differences
K150573 · PDF page 4 ↗ Source 2
The ebb Complete Tamponade S ystem and the predicate have the same technological
characteristics. Both devices are disposable, multiple lumen catheters attached to an inflatable
balloon system designed to provide tamponade for controlling hemorrhage from the uterus and
vagina.
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 summary’s comparison is a manufacturer statement about that submission. Investigate the actual design differences and cited records before considering any comparator or predicate.
Performance evidence actually described
K150573 · PDF page 5 ↗ Source 3
Testing performed on the modified devices demonstrated significant improvement in strength over
the previous version. The testing consisted of subjecting the device to physiologic pressures under
worst-case conditions. None of the modified devices failed under those conditions.
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}.
