510(k) · Cleared

Cleared

Tamponade Uterine Balloon Catheter Set

K013597510(k) TraditionalCleared Apr 17, 2002168-day reviewClass II21 CFR 884.4530

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cook Ob/Gyn · KNA Instrument, Manual, Specialized Obstetric-Gynecologic

Cleared on Apr 17, 2002 after a 168-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided: Apr 17, 2002
Review: 168 days
Class: Class II
Product code: KNA
Recalls: None
Predicates: 0

14 later devices descend from it, 4 citing it directly.

This deviceK013597 Tamponade Uterine Balloon Catheter SetCook Ob/Gyn · 2002
Descendant · cites it directly · 11 of its ownK062438 Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
Descendant · 2 generations on · 6 of its ownK170622 Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid…Cook Incorporated · 2017
Descendant · cites it directly · 4 of its ownK060289 Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006
Descendant · 3 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

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2006high 2 (2006) · low 0 (2007)2026

Most influential descendants

Showing 5 of 14 · See all

K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006 · cites it directly11descendants
K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated · 2017 · 2 generations on6descendants
K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006 · cites it directly4descendants
K201199Jada SystemAlydia Health · 2020 · 3 generations on2descendants
K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010 · cites it directly2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K013597	Tamponade Uterine Balloon Catheter Set	Cook Ob/Gyn	2002	—
+1	K062438	Bakri Postpartum Balloon, Model J-Sos-100500	Cook Ob/Gyn	2006	—
+2	K170622	Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation…	Cook Incorporated	2017	—
+1	K060289	Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01	Frontline Medical	2006	—
+3	K201199	Jada System	Alydia Health	2020	—
+1	K091958	Belfort-Dildy Obstetric Tamponade System	Glenveigh Surgical, LLC	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	2	0
2010	2	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

FIG. 1 — Lineage of K013597, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	—	Mentor U-Stasis Balloon Named without a submission number			—
*	—	Balloon Uterine Stent Named without a submission number			—

What descends from it? (14)

See all 14

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062438	Bakri Postpartum Balloon, Model J-Sos-100500	Cook Ob/Gyn	2006	11
K060289	Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01	Frontline Medical	2006	4
K091958	Belfort-Dildy Obstetric Tamponade System	Glenveigh Surgical, LLC	2010	2
K101535	BT-Cath	Utah Medical Products, Inc.	2011	0

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?

Of its descendants, K062438 (Cook Ob/Gyn, 2006) has gone furthest, with 11 descendants of its own.

How does its category compare?

All KNA devices

KNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNA

1in 2014

2007high 1 (2009) · low 0 (2007)2026

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

2007high 63 (2018) · low 0 (2008)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	MAUDE reports
2007	0	—	2
2008	0	—	0
2009	1	—	0
2010	1	—	8
2011	1	—	13
2012	0	—	8
2013	0	—	2
2014	1	—	4
2015	0	—	8
2016	0	—	22
2017	0	—	37
2018	0	—	63
2019	0	—	5
2020	0	—	0
2021	0	—	2
2022	0	—	4
2023	0	—	2
2024	0	—	1
2025	0	—	5
2026	0	—	—

What is it indicated for?

The Tamponade Uterine Balloon Catheter Set is intended to provide

temporary control or reduction of post-partum uterine bleeding when

conservative management is warranted. The device is one time use and

is supplied sterile.

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/K013597 · printed Nov 4, 2026

Cite this page

510(k) Report. “K013597: Tamponade Uterine Balloon Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013597

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026