510(k) · Cleared
ClearedDacomed External Male Continence Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dacomed Corp. · FHA Clamp, Penile
Cleared on Feb 8, 1989 after a 42-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
- Feb 8, 1989
- Review
- 42 days
- Class
- Class I
- Product code
- FHA
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK885323 Dacomed External Male Continence DeviceDacomed Corp. · 1989
- Descendant · cites it directly · 0 of its ownK974040 C3 External Male Bladder Control DeviceTimm Research Co. · 1998
- Descendant · cites it directly · 0 of its ownK971992 Uromed Alternative Bladder Control Continence Device (Abcpn-0026)Uromed Corp. · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885323 | Dacomed External Male Continence Device | Dacomed Corp. | 1989 | — |
| +1 | K974040 | C3 External Male Bladder Control Device | Timm Research Co. | 1998 | — |
| +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 |
| 1998 | 1 | 0 |
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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K974040 (Timm Research Co., 1998) 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 | — |
https://510kreport.com/device/K885323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K885323: Dacomed External Male Continence Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K885323
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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