510(k) Report

510(k) · Cleared

Cleared

Belfort-Dildy Obstetric Tamponade System

K091958510(k) TraditionalCleared Apr 30, 2010303-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

Glenveigh Surgical, LLC · OQY Intrauterine Tamponade Balloon

Cleared on Apr 30, 2010 as substantially equivalent to K062438 (Cook Ob/Gyn, 2006) and 3 other predicates after a 303-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.

Decided
Apr 30, 2010
Review
303 days
Class
Class II
Product code
OQY
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K972077 (1997). 5 ancestors in all, the oldest K862480 (1986). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2002: 1 other ancestor1986: 1 other ancestor2015: 1 descendant cleared2016: 1 descendant clearedK972077 · Epi-Stop Epistaxis Catheter · Boston Medical Products, Inc. · 1997K060289 · Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 · Frontline Medical · 20061990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K060289 · Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 · Frontline Medical · 2006K972077 · Epi-Stop Epistaxis Catheter · Boston Medical Products, Inc. · 19970
  1. Root · 2 generations backK972077 Epi-Stop Epistaxis CatheterBoston Medical Products, Inc. · 1997
  2. 1 generation backK060289 Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006
  3. This deviceK091958 Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010
  4. Descendant · cites it directly · 1 of its ownK150573 ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK153591 ebb Complete Tamponade SystemClinical Innovations, LLC · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K150573ebb Complete Tamponade SystemClinical Innovations, LLC · 2015 · cites it directly1descendant
  • K153591ebb Complete Tamponade SystemClinical Innovations, LLC · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K972077Epi-Stop Epistaxis CatheterBoston Medical Products, Inc.1997—
−1K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical2006—
0 (this device)K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC2010—
+1K150573ebb Complete Tamponade SystemClinical Innovations, LLC20151
+2K153591ebb Complete Tamponade SystemClinical Innovations, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
200210
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201610
FIG. 1 — Lineage of K091958, 1997–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253642 Jada System (Jada-2002)score 12.5 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K062438Bakri Postpartum Balloon, Model J-Sos-100500
Summary page 1
…alloon DEVICE CLASSIFICATION: Class II per 21 CIFR §884.4530 PRODUCT CODE: OQY 1.3 PREDICATE DEVICE INFORMATION PREDICATE K062438 & K013597 Cook Bakri Postpartum Tamponade Balloon DEVICE: K060289 Frontline Vaginal Tamponade Balloon…
Cook Ob/Gyn2006—
*K013597Tamponade Uterine Balloon Catheter Set
Summary page 1
…DEVICE CLASSIFICATION: Class II per 21 CIFR §884.4530 PRODUCT CODE: OQY 1.3 PREDICATE DEVICE INFORMATION PREDICATE K062438 & K013597 Cook Bakri Postpartum Tamponade Balloon DEVICE: K060289 Frontline Vaginal Tamponade Balloon…
Cook Ob/Gyn2002—
*K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01
Summary page 1
…ODUCT CODE: OQY 1.3 PREDICATE DEVICE INFORMATION PREDICATE K062438 & K013597 Cook Bakri Postpartum Tamponade Balloon DEVICE: K060289 Frontline Vaginal Tamponade Balloon K862480 Utah Medical BT Cath Uterine Tamponade Balloon SUBSTANTIAL EQ…
Frontline Medical2006—
*K862480BT Cath (Intravascular Catheter)
Summary page 1
…PREDICATE K062438 & K013597 Cook Bakri Postpartum Tamponade Balloon DEVICE: K060289 Frontline Vaginal Tamponade Balloon K862480 Utah Medical BT Cath Uterine Tamponade Balloon SUBSTANTIAL EQUIVALENCE: The Belfort-Dildy Obstetric Tamponade System is substan…
Baron Technologies, Inc.1986—

Also cleared against K062438: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150573ebb Complete Tamponade SystemClinical Innovations, LLC20151

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 13 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
  • None of the 5 ancestors has a recall.
  • Of its descendants, K150573 (Clinical Innovations, LLC, 2015) has gone furthest, with 1 descendant of its own.
  • 2 other devices also cite its predicate K062438.

How does its category compare?

All OQY devices

OQY Intrauterine Tamponade Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · OQY

1in 2023

2010: 12011: 12015: 12016: 12017: 12019: 12020: 12021: 12022: 12023: 12026 (partial year): 1
2007high 1 (2010) · low 0 (2007)2026

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

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OQY

176in 2025

2011: 12013: 22014: 42015: 52016: 92017: 32018: 552019: 902020: 902021: 1132022: 2742023: 2282024: 2152025: 176
2007high 274 (2022) · low 0 (2007)2025

MAUDE reports naming product code OQY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20101—00
20111—01
20120—00
20130—02
20140—14
20151—15
20161—09
20171—03
20180—055
20191—090
20201—090
20211—0113
20221—0274
20231—0228
20240—0215
20250—0176
20261—0—

What is it indicated for?

The Belfort-Dildy Obstetric Tamponade System (OTS) is indicated for use in providing temporary control or reduction of postpartum uterine bleeding. Inflation of the Vaginal Balloon anchors the Uterine Balloon and provides vaginal tamponade if vaginal bleeding is present. The OTS should only be used in the setting of post-partum uterine bleeding when conservative management is warranted.

Indications for use as stated in the FDA summary.

Also cleared against K062438

2 other devices cite the same predicate.

  • K170622Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation ComponentCook Incorporated · 2017
  • K101535BT-CathUtah Medical Products, Inc. · 2011

More from Glenveigh Surgical, LLC

2 FDA decisions under this applicant name. See the company

  • K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010

Recent decisions in OQY

The OQY category page

  • K253642Jada System (Jada-2002)Organon, LLC · 2026
  • K230849Ellavi UbtSinapi Biomedical (Pty), Ltd. · 2023
  • K223098Bakri Essential Postpartum BalloonCook Incorporated · 2022
  • K212757Jada SystemAlydia Health · 2021
  • K201199Jada SystemAlydia Health · 2020

https://510kreport.com/device/K091958 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091958: Belfort-Dildy Obstetric Tamponade System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091958

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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