510(k) · Cleared
Recalled · 2007Duna II Penile Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dacomed Corp. · FAE Prosthesis, Penile
Cleared on Oct 27, 1995 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 27, 1995
- Review
- 84 days
- Class
- Class II
- Product code
- FAE
- Recalls
- 2
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK953640 Duna II Penile ProsthesisDacomed Corp. · 1995
- Descendant · cites it directly · 1 of its ownK082006 Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK090663 Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2009
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) | K953640 | Duna II Penile Prosthesis | Dacomed Corp. | 1995 | — |
| +1 | K082006 | Ams Spectra Concealable Penile Prosthesis | American Medical Systems, Inc. | 2008 | — |
| +1 | K090663 | Ams Spectra Concealable Penile Prosthesis | American Medical Systems, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 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 FAE? 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 19, 2007 | Not classified | Z-0702-2007 | Other | Mis-labeling: The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
| Feb 19, 2007 | Not classified | Z-0703-2007 | Other | Mis-Labeling:The Dura-II 2 cm Universal Tips and the Dura-II 4 cm Distal Tips were incorrectly labeled with the opposite labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082006 (American Medical Systems, Inc., 2008) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FAE devicesFAE Prosthesis, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FAE
2in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · FAE
Too few FAE 510(k)s in any year since 2007 to give a median.
Recalls per year · FAE
2in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FAE
195in 2025
MAUDE reports naming product code FAE, 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 | — | 2 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 87 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 108 |
| 2014 | 0 | — | 0 | 75 |
| 2015 | 0 | — | 0 | 98 |
| 2016 | 0 | — | 0 | 104 |
| 2017 | 0 | — | 0 | 123 |
| 2018 | 0 | — | 0 | 127 |
| 2019 | 2 | — | 0 | 221 |
| 2020 | 0 | — | 0 | 163 |
| 2021 | 0 | — | 0 | 167 |
| 2022 | 0 | — | 0 | 168 |
| 2023 | 0 | — | 0 | 160 |
| 2024 | 0 | — | 0 | 187 |
| 2025 | 0 | — | 0 | 195 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K953640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953640: Duna II Penile Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953640
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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