510(k) Report

510(k) · Cleared

Recalled · 2003

Urinary Leg Bag

K780032510(k) TraditionalCleared Jan 17, 19788-day reviewClass I21 CFR 876.5250Recalls 1

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

C.R. Bard, Inc. · FAQ Bag, Urine Collection, Leg, For External Use, Sterile

Cleared on Jan 17, 1978 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Jan 17, 1978
Review
8 days
Class
Class I
Product code
FAQ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared19801990200020102020
  1. This deviceK780032 Urinary Leg BagC.R. Bard, Inc. · 1978
  2. Descendant · cites it directly · 0 of its ownK972887 Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary…Medline Industries, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all
  • K972887Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagMedline Industries, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K780032Urinary Leg BagC.R. Bard, Inc.1978—
+1K972887Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagMedline Industries, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
FIG. 1 — Lineage of K780032, 1978–1997Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in FAQ? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K972887Medline Premium Leg Bag, Medline Fabric Bac Leg Bag, Medline Urinary Leg BagMedline Industries, Inc.19970

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 25, 2003Not classifiedZ-0732-03OtherThere is a potential for package seals to be open after sterilization.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K972887 (Medline Industries, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All FAQ devices

FAQ Bag, Urine Collection, Leg, For External Use, Sterile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAQ

FDA has decided no FAQ device since 2007.

Median 510(k) review, days · FAQ

Too few FAQ 510(k)s in any year since 2007 to give a median.

Recalls per year · FAQ

3in 2023

2011: 22023: 3
2007high 3 (2023) · low 0 (2007)2026

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

Adverse event reports per year · FAQ

16in 2025

2007: 12008: 32009: 32010: 172011: 122012: 132013: 92014: 42015: 12016: 132017: 222018: 32019: 32020: 12021: 702022: 482023: 362024: 422025: 16
2007high 70 (2021) · low 1 (2007)2025

MAUDE reports naming product code FAQ, 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—01
20080—03
20090—03
20100—017
20110—212
20120—013
20130—09
20140—04
20150—01
20160—013
20170—022
20180—03
20190—03
20200—01
20210—070
20220—048
20230—336
20240—042
20250—016
20260—0—

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

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  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

Recent decisions in FAQ

The FAQ category page

  • K962604Prosys Custom Fit Leg Bag with Preattached Adjustable Inlet Tube for Patient SizingConvatec, A Division of E.R. Squibb & Sons · 1996
  • K960217CPR Urine BagCustom Pack Reliability · 1996
  • K955609Conveen Urine Bag - SterileColoplast Corp. · 1995
  • K953767Prosys Bedside Drainage BagConvatec, A Division of E.R. Squibb & Sons · 1995
  • K953783Conveen Leg Bag StrapColoplast Corp. · 1995

https://510kreport.com/device/K780032 · printed Nov 6, 2026

Cite this page

510(k) Report. “K780032: Urinary Leg Bag.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K780032

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026