510(k) · Cleared

Cleared

Uromed Alternative Bladder Control Continence Device (Abcpn-0026)

K971992510(k) TraditionalCleared Aug 1, 199764-day reviewClass I21 CFR 876.5160

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

Cleared on Aug 1, 1997 as substantially equivalent to K964580 (Nebel, Inc., 1997) and 2 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1995.

Decided: Aug 1, 1997
Review: 64 days
Class: Class I
Product code: FHA
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K954959 (1995). 4 ancestors in all, the oldest K885323 (1989). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK954959 Cap-AidNebl, Inc. · 1995
1 generation backK964580 Cap-Aid (Improved)Nebel, Inc. · 1997
This deviceK971992 Uromed Alternative Bladder Control Continence Device (Abcpn-0026)Uromed Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K954959	Cap-Aid	Nebl, Inc.	1995	—
−1	K964580	Cap-Aid (Improved)	Nebel, Inc.	1997	—
0 (this device)	K971992	Uromed Alternative Bladder Control Continence Device (Abcpn-0026)	Uromed Corp.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1995	1	0

FIG. 1 — Lineage of K971992, 1995–1997Source: 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 FHA? 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K964580	Cap-Aid (Improved) Summary page 1 …re currently marketed with either pre-amendment status or current PreMarket notification numbers: Product Name Manufacturer S10¢k) # Cap-Aid Continence Device NEBL Inc. K964580 C' Male Continence Device Dacomed Corp. K885323 Male Assistant Insight Medical Corp. K952841 Cunningham Clamp Bard ' pre-amendm…	Nebel, Inc.	1997	—
*	K885323	Dacomed External Male Continence Device Summary page 1 …tatus or current PreMarket notification numbers: Product Name Manufacturer S10¢k) # Cap-Aid Continence Device NEBL Inc. K964580 C' Male Continence Device Dacomed Corp. K885323 Male Assistant Insight Medical Corp. K952841 Cunningham Clamp Bard ' pre-amendment Intended Use The UroMed ABC device is inten…	Dacomed Corp.	1989	—
*	K952841	The Assistant Summary page 1 …s: Product Name Manufacturer S10¢k) # Cap-Aid Continence Device NEBL Inc. K964580 C' Male Continence Device Dacomed Corp. K885323 Male Assistant Insight Medical Corp. K952841 Cunningham Clamp Bard ' pre-amendment Intended Use The UroMed ABC device is intended to prevent or reduce episodes of male urin…	Apple Medical Corp.	1995	—
*	—	Cunningham Clamp Named without a submission number			—

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 2 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All FHA devices

FHA Clamp, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FHA

FDA has decided no FHA device since 2007.

Median 510(k) review, days · FHA

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

Recalls per year · FHA

No recall names FHA since 2007.

Adverse event reports per year · FHA

1in 2023

2007high 5 (2014) · low 0 (2007)2025

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

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	1
2011	—	0
2012	—	1
2013	—	1
2014	—	5
2015	—	0
2016	—	0
2017	—	5
2018	—	5
2019	—	3
2020	—	1
2021	—	0
2022	—	2
2023	—	1
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The UroMed ABC device is indicated to prevent or reduce episodes of male urinary incontinence.

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/K971992 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971992: Uromed Alternative Bladder Control Continence Device (Abcpn-0026).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971992

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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