510(k) Report

510(k) · Cleared

Cleared

Mentor Self-Cath Closed System

K003873510(k) TraditionalCleared Mar 29, 2001104-day reviewClass II21 CFR 876.5130

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

Mentor Corp. · FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)

Cleared on Mar 29, 2001 after a 104-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Mar 29, 2001
Review
104 days
Class
Class II
Product code
FCM
Recalls
None
Predicates
0

27 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2005: 2 descendants cleared2002: 1 descendant cleared2007: 2 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2016: 2 descendants cleared2008: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2018: 2 descendants cleared2015: 2 descendants cleared2019: 2 descendants cleared2022: 3 descendants cleared2024: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant cleared200020052010201520202025
  1. This deviceK003873 Mentor Self-Cath Closed SystemMentor Corp. · 2001
  2. Descendant · cites it directly · 20 of its ownK013483 Incare Advance; Intermittent Catheter, Plus Intermittent Catheter…Hollister, Inc. · 2002
  3. Descendant · 2 generations on · 15 of its ownK090960 Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142…Hollister, Inc. · 2009
  4. Descendant · 2 generations on · 14 of its ownK110862 Vapro Plus Intermittent CatheterHollister Incorporated · 2011
  5. Descendant · 3 generations on · 13 of its ownK141642 Vapro Intermittent CatheterHollister Incorporated · 2014
  6. Descendant · 4 generations on · 6 of its ownK180824 VaPro 2 Intermittent CatheterHollister Incorporated · 2018

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2002: 12004: 22005: 22007: 22008: 12009: 12011: 22014: 12015: 22016: 22017: 12018: 22019: 22022: 32024: 12025: 12026: 1
2002high 3 (2022) · low 0 (2003)2026

Most influential descendants

Showing 5 of 27 · See all
  • K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc. · 2002 · cites it directly20descendants
  • K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…Hollister, Inc. · 2009 · 2 generations on15descendants
  • K110862Vapro Plus Intermittent CatheterHollister Incorporated · 2011 · 2 generations on14descendants
  • K141642Vapro Intermittent CatheterHollister Incorporated · 2014 · 3 generations on13descendants
  • K180824VaPro 2 Intermittent CatheterHollister Incorporated · 2018 · 4 generations on6descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003873Mentor Self-Cath Closed SystemMentor Corp.2001—
+1K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc.2002—
+2K090960Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064…Hollister, Inc.2009—
+2K110862Vapro Plus Intermittent CatheterHollister Incorporated2011—
+3K141642Vapro Intermittent CatheterHollister Incorporated2014—
+4K180824VaPro 2 Intermittent CatheterHollister Incorporated2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200420
200520
200720
200810
200910
201120
201410
201520
201620
201710
201820
201920
202230
202410
202510
202610
FIG. 1 — Lineage of K003873, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 FCM? 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 FCM device

  1. #1 K254076 BD Touchless™ Plus Unisex Pre-Lubricated…score 11.4 · 1 generation · 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?

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

What descends from it? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K013483Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitHollister, Inc.200220
K052440Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corporation20053
K032710Closed System Intermittent Catheterization KitApogee Medical, Inc.20042
K070939Self-Cath CS Closed Urinary Catheterization SystemColoplast Manufacturing Us, LLC20070
K050008Mentor Self-Cath Hydrogel Intermittent CatheterMentor Corp.20050
K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp.20040

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, K013483 (Hollister, Inc., 2002) has gone furthest, with 20 descendants of its own.

How does its category compare?

All FCM devices

FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FCM

1in 2025

2007: 22008: 12023: 12025: 12026 (partial year): 1
2007high 2 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FCM

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

Recalls per year · FCM

1in 2023

2011: 312022: 62023: 1, 1 Class I
2007high 31 (2011) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · FCM

35in 2025

2007: 12008: 32009: 62010: 32011: 42012: 32013: 42014: 62015: 52016: 142017: 332018: 612019: 792020: 862021: 852022: 592023: 482024: 542025: 35
2007high 86 (2020) · low 1 (2007)2025

MAUDE reports naming product code FCM, 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
20072—01
20081—03
20090—06
20100—03
20110—314
20120—03
20130—04
20140—06
20150—05
20160—014
20170—033
20180—061
20190—079
20200—086
20210—085
20220—659
20231—1 (1)48
20240—054
20251—035
20261—0—

More from Mentor Corp.

146 FDA decisions under this applicant name. See the company

  • P030053/S093MemoryGel™ Breast ImplantsMentor Corp. · 2026
  • P030053/S085MENTOR™ MemoryGel™ Breast ImplantsMentor Corp. · 2026
  • P030053/S083MENTOR™ MemoryGel™ Enhance Breast ImplantsMentor Corp. · 2026
  • P030053/S089MENTOR™ MemoryGel™ Silicone Gel-Filled Breast ImplantsMentor Corp. · 2026
  • P030053/S088MemoryGel Silicone Gel-Filled Breast ImplantMentor Corp. · 2026

Recent decisions in FCM

The FCM category page

  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026
  • K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90)…Convatec Limited · 2025
  • K223821Self-Cath Closed SystemColoplast · 2023
  • K082831Amself Closed Catheterization SystemAmsino International, Inc. · 2008
  • K070939Self-Cath CS Closed Urinary Catheterization SystemColoplast Manufacturing Us, LLC · 2007

https://510kreport.com/device/K003873 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003873: Mentor Self-Cath Closed System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003873

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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