510(k) · Cleared
ClearedCap-Aid (Improved)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nebel, Inc. · FHA Clamp, Penile
Cleared on Jan 10, 1997 as substantially equivalent to K954959 (Nebl, Inc., 1995) after a 56-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Jan 10, 1997
- Review
- 56 days
- Class
- Class I
- Product code
- FHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954959 (1995). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K971992Uromed Alternative Bladder Control Continence Device (Abcpn-0026)Uromed Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954959 | Cap-Aid | Nebl, Inc. | 1995 | — |
| 0 (this device) | K964580 | Cap-Aid (Improved) | Nebel, Inc. | 1997 | — |
| +1 | 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 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954959 | Cap-AidSummary page 2…The product prevents urinary leakage in men with urinary incontinence. Substantial Equivalence Comparison NEBL Inc. CAP-AID NEBL Inc. CAP-AID (Improved) (original) K954959 Indication Prevent urine leakage in Prevent urine leakage in male incontinence male incontinence Mode of External device which Ex… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K971992 | Uromed Alternative Bladder Control Continence Device (Abcpn-0026) | 1997 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K971992 (Uromed Corp., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FHA devicesFHA 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
MAUDE reports naming product code FHA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The product prevents urinary leakage in men with 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/K964580 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964580: Cap-Aid (Improved).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964580
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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