510(k) · Cleared

Cleared

Cap-Aid

K954959510(k) TraditionalCleared Dec 6, 199540-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 Dec 6, 1995 after a 40-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided: Dec 6, 1995
Review: 40 days
Class: Class I
Product code: FHA
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK954959 Cap-AidNebl, Inc. · 1995
Descendant · cites it directly · 1 of its ownK964580 Cap-Aid (Improved)Nebel, Inc. · 1997
Descendant · 2 generations on · 0 of its ownK971992 Uromed Alternative Bladder Control Continence Device (Abcpn-0026)Uromed Corp. · 1997

Most influential descendants

Showing 2 of 2 · See all

K964580Cap-Aid (Improved)Nebel, Inc. · 1997 · cites it directly1descendant
K971992Uromed Alternative Bladder Control Continence Device (Abcpn-0026)Uromed Corp. · 1997 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K954959, 1995–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

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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? (2)

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

Number	Device	Applicant	Decided	Descendants
K964580	Cap-Aid (Improved)	Nebel, Inc.	1997	1

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, K964580 (Nebel, Inc., 1997) has gone furthest, with 1 descendant of its own.

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	—	—

https://510kreport.com/device/K954959 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954959: Cap-Aid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954959

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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