510(k) · Cleared
ClearedBakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component
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 Mar 31, 2017 as substantially equivalent to K062438 (Cook Ob/Gyn, 2006) after a 30-day review. Its family tree reaches back 2 generations to 2002. 6 later devices descend from it.
- Decided
- Mar 31, 2017
- Review
- 30 days
- Class
- Class II
- Product code
- OQY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013597 (2002). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK013597 Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
- 1 generation backK062438 Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
- This deviceK170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid…Cook Incorporated · 2017
- Descendant · cites it directly · 2 of its ownK201199 Jada SystemAlydia Health · 2020
- Descendant · 2 generations on · 1 of its ownK212757 Jada SystemAlydia Health · 2021
- Descendant · 3 generations on · 0 of its ownK253642 Jada System (Jada-2002)Organon, LLC · 2026
- Descendant · cites it directly · 0 of its ownK230849 Ellavi UbtSinapi Biomedical (Pty), Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK223098 Bakri Essential Postpartum BalloonCook Incorporated · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201199Jada SystemAlydia Health · 2020 · cites it directly2descendants
- K212757Jada SystemAlydia Health · 2021 · 2 generations on1descendant
- K253642Jada System (Jada-2002)Organon, LLC · 2026 · 3 generations on0descendants
- K230849Ellavi UbtSinapi Biomedical (Pty), Ltd. · 2023 · cites it directly0descendants
- K223098Bakri Essential Postpartum BalloonCook Incorporated · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013597 | Tamponade Uterine Balloon Catheter Set | Cook Ob/Gyn | 2002 | — |
| −1 | K062438 | Bakri Postpartum Balloon, Model J-Sos-100500 | Cook Ob/Gyn | 2006 | — |
| 0 (this device) | K170622 | Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation… | Cook Incorporated | 2017 | — |
| +1 | K201199 | Jada System | Alydia Health | 2020 | — |
| +2 | K212757 | Jada System | Alydia Health | 2021 | — |
| +3 | K253642 | Jada System (Jada-2002) | Organon, LLC | 2026 | — |
| +1 | K230849 | Ellavi Ubt | Sinapi Biomedical (Pty), Ltd. | 2023 | — |
| +1 | K223098 | Bakri Essential Postpartum Balloon | Cook Incorporated | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K062438 | Bakri Postpartum Balloon, Model J-Sos-100500Summary page 5…um uterine bleeding when conservative management is warranted. Predicate Device: The predicate device, the Bakri® Postpartum Balloon manufactured by Cook Incorporated (K062438), is a medical device intended to provide temporary control or reduction of postpartum uterine bleeding when conservative managem… | 2006 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K201199 (Alydia Health, 2020) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K062438.
How does its category compare?
All OQY devicesOQY Intrauterine Tamponade Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Bakri® Postpartum Balloon is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.
Bakri® Postpartum Balloon with Rapid Instillation Components 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/K170622 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170622: Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170622
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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