510(k) · Cleared
ClearedBakri Postpartum Balloon, Model J-Sos-100500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Ob/Gyn · KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Cleared on Oct 27, 2006 as substantially equivalent to K013597 (Cook Ob/Gyn, 2002) after a 67-day review. Its family tree reaches back 1 generation to 2002. 11 later devices descend from it.
- Decided
- Oct 27, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- KNA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K013597 (2002). 11 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK013597 Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
- This deviceK062438 Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
- Descendant · cites it directly · 6 of its ownK170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid…Cook Incorporated · 2017
- Descendant · 2 generations on · 2 of its ownK201199 Jada SystemAlydia Health · 2020
- Descendant · cites it directly · 2 of its ownK091958 Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010
- Descendant · 3 generations on · 1 of its ownK212757 Jada SystemAlydia Health · 2021
- Descendant · 2 generations on · 1 of its ownK150573 ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated · 2017 · cites it directly6descendants
- K201199Jada SystemAlydia Health · 2020 · 2 generations on2descendants
- K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010 · cites it directly2descendants
- K212757Jada SystemAlydia Health · 2021 · 3 generations on1descendant
- K150573ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013597 | Tamponade Uterine Balloon Catheter Set | Cook Ob/Gyn | 2002 | — |
| 0 (this device) | 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 | — |
| +2 | K201199 | Jada System | Alydia Health | 2020 | — |
| +1 | K091958 | Belfort-Dildy Obstetric Tamponade System | Glenveigh Surgical, LLC | 2010 | — |
| +3 | K212757 | Jada System | Alydia Health | 2021 | — |
| +2 | K150573 | ebb Complete Tamponade System | Clinical Innovations, LLC | 2015 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 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 KNA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K013597 | Tamponade Uterine Balloon Catheter SetSummary page 1…cologic KNA Predicate Devices: The Bakri Postpartum Balloon isidentical to the currently marketed SOS Bakri Tamnponade Balloon Set (K013597). The purpose of this submission isto request clearance for the removal of uterine atony as a contraindlication for use. Indica… | 2002 |
What descends from it? (11)
See all 113 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?
How does its category compare?
All KNA devicesKNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KNA
Too few KNA 510(k)s in any year since 2007 to give a median.
Recalls per year · KNA
No recall names KNA since 2007.
Adverse event reports per year · KNA
5in 2025
MAUDE reports naming product code KNA, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Bakri Postpartum Balloon 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/K062438 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062438: Bakri Postpartum Balloon, Model J-Sos-100500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062438
Report an extraction error
Are you the manufacturer?
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