510(k) Report

510(k) · Cleared

Cleared

Glenveigh Vaginal Tamponade Balloon Catheter

K093904510(k) TraditionalCleared Apr 14, 2010113-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 · KNA Instrument, Manual, Specialized Obstetric-Gynecologic

Cleared on Apr 14, 2010 as substantially equivalent to K060289 (Frontline Medical, 2006) after a 113-day review. Its family tree reaches back 2 generations to 1997.

Decided
Apr 14, 2010
Review
113 days
Class
Class II
Product code
KNA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K972077 (1997). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK972077 · Epi-Stop Epistaxis Catheter · Boston Medical Products, Inc. · 1997K060289 · Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01 · Frontline Medical · 20061995200020052010
Other ancestors, by generation 2 generations back: 1 other ancestor 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 deviceK093904 Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC · 2010
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)K093904Glenveigh Vaginal Tamponade Balloon CatheterGlenveigh Surgical, LLC2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K093904, 1997–2010Source: 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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01
Summary page 1
…Iper 21 CFR §884.4530 CLASSIFICATION AND PRODUCT Product Code: KNA CODE PREDICATE EpiStatNV-Stat Vaginal Tamponade Balloon (K060289) DEVICE NAME Cleared July 7, 2006 Gauze Packing SUBSTANTIAL EQUIVALENCE: The Glenvei…
Frontline Medical2006—

Also cleared against K060289: 1 other device →

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 13 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
  • None of the 3 ancestors has a recall.
  • 1 other device also cites its predicate K060289.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · KNA

1in 2014

2009: 12010: 12011: 12014: 1
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

2007: 22010: 82011: 132012: 82013: 22014: 42015: 82016: 222017: 372018: 632019: 52021: 22022: 42023: 22024: 12025: 5
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—00
20091—00
20101—08
20111—013
20120—08
20130—02
20141—04
20150—08
20160—022
20170—037
20180—063
20190—05
20200—00
20210—02
20220—04
20230—02
20240—01
20250—05
20260—0—

What is it indicated for?

The Glenveigh Vaginal Repair Balloon is indicated for use during episiotomy/vaginal

laceration repair to temporarily prevent the post partumn discharge of fluids from the vagina

in order to assist with the episiotomy/laceration repair procedure.

Indications for use as stated in the FDA summary.

Also cleared against K060289

1 other device cites the same predicate.

  • K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010

More from Glenveigh Surgical, LLC

2 FDA decisions under this applicant name. See the company

  • K091958Belfort-Dildy Obstetric Tamponade SystemGlenveigh Surgical, LLC · 2010

Recent decisions in KNA

The KNA category page

  • K130087Panpac Word/Bartholin CatheterPanpac Medical Corporation · 2014
  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K062438Bakri Postpartum Balloon, Model J-Sos-100500Cook Ob/Gyn · 2006
  • K060289Epistat, V-Stat, Models Epistat-001-01, V-Stat-001-01Frontline Medical · 2006

https://510kreport.com/device/K093904 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093904: Glenveigh Vaginal Tamponade Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093904

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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