510(k) · Cleared
ClearedBakri Essential Postpartum Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · OQY Intrauterine Tamponade Balloon
Cleared on Oct 28, 2022 as substantially equivalent to K170622 (Cook Incorporated, 2017) after a 28-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Oct 28, 2022
- Review
- 28 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 deviceK223098 Bakri Essential Postpartum BalloonCook Incorporated · 2022
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) | K223098 | Bakri Essential Postpartum Balloon | Cook Incorporated | 2022 | — |
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 12.6 · 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…II Product Code: OQY, Intrauterine Tamponade Balloon Predicate Device Bakri Postpartum Balloon, manufactured by Cook Incorporated (K170622). The predicate device has not been subject to a design-related recall. Device Description The Bakri Essential Postpartum Ball… | 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 20 years and passes through 2 companies; a new generation was cleared every 5.6 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. 2022, 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 Bakri Essential Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223098 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223098: Bakri Essential Postpartum Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223098
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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