510(k) · Cleared
Clearedebb Complete Tamponade System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinical Innovations, LLC · OQY Intrauterine Tamponade Balloon
Cleared on Jan 14, 2016 as substantially equivalent to K150573 (Clinical Innovations, LLC, 2015) after a 29-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jan 14, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- OQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K972077 (1997). 7 ancestors in all, the oldest K862480 (1986). No later device cites it as a predicate yet.
- Root · 4 generations backK972077 Epi-Stop Epistaxis CatheterBoston Medical Products, Inc. · 1997
- 3 generations backK060289 Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006
- 2 generations backK091958 Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010
- 1 generation backK150573 ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · Recalled
- This deviceK153591 ebb Complete Tamponade SystemClinical Innovations, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972077 | Epi-Stop Epistaxis Catheter | Boston Medical Products, Inc. | 1997 | — |
| −3 | K060289 | Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 | Frontline Medical | 2006 | — |
| −2 | K091958 | Belfort-Dildy Obstetric Tamponade System | Glenveigh Surgical, LLC | 2010 | — |
| −1 | K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015 | 1 |
| 0 (this device) | K153591 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OQY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OQY device
- #1 K253642 Jada System (Jada-2002)score 12.5 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150573 | ebb Complete Tamponade SystemSummary page 4…S. Murray, UT 84123 Common or Usual Name: Intrauterine tamponade balloon Classification Name: Class II per 21 CFR 884.4530 Product Code: OQY Predicate Device: K150573 ebb Complete Tamponade System Purpose of the Special 510(k) notice: The subject ebb Complete Tamponade System is a modi… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All OQY devicesOQY Intrauterine Tamponade Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OQY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OQY
Too few OQY 510(k)s in any year since 2007 to give a median.
Recalls per year · OQY
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OQY
176in 2025
MAUDE reports naming product code OQY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 1 | 4 |
| 2015 | 1 | — | 1 | 5 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 55 |
| 2019 | 1 | — | 0 | 90 |
| 2020 | 1 | — | 0 | 90 |
| 2021 | 1 | — | 0 | 113 |
| 2022 | 1 | — | 0 | 274 |
| 2023 | 1 | — | 0 | 228 |
| 2024 | 0 | — | 0 | 215 |
| 2025 | 0 | — | 0 | 176 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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 ebb Complete Tamponade System should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153591 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153591: ebb Complete Tamponade System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153591
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026