510(k) · Cleared
ClearedEvery Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ujenzi Charitable Trust · OQY Intrauterine Tamponade Balloon
Cleared on Oct 30, 2019 as substantially equivalent to K170622 (Cook Incorporated, 2017) after a 173-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 30, 2019
- Review
- 173 days
- Class
- Class II
- Product code
- OQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013597 (2002). No later device cites it as a predicate yet.
- Root · 3 generations backK013597 Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
- 2 generations backK062438 Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
- 1 generation backK170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid…Cook Incorporated · 2017
- This deviceK191264 Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”)Ujenzi Charitable Trust · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013597 | Tamponade Uterine Balloon Catheter Set | Cook Ob/Gyn | 2002 | — |
| −2 | K062438 | Bakri Postpartum Balloon, Model J-Sos-100500 | Cook Ob/Gyn | 2006 | — |
| −1 | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation… | Cook Incorporated | 2017 | — |
| 0 (this device) | K191264 | Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) | Ujenzi Charitable Trust | 2019 | — |
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 |
|---|---|---|---|
| * | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentSummary page 4…Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component 510(k) Number: K170622 Manufacturer: Cook Incorporated Regulatory Class: Class II Product Code:… | 2017 |
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 17 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K170622.
How does its category compare?
All OQY devicesOQY Intrauterine Tamponade Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 ESM-UBT device is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191264: Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191264
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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