510(k) · Cleared
ClearedAms Spectra Concealable Penile Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · FAE Prosthesis, Penile
Cleared on Oct 20, 2008 as substantially equivalent to K953640 (Dacomed Corp., 1995) and 2 other predicates after a 97-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Oct 20, 2008
- Review
- 97 days
- Class
- Class II
- Product code
- FAE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K912935 (1992). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK912935 Ams Malleable 600 and 600M Penile ProsthesisAmerican Medical Systems, Inc. · 1992
- This deviceK082006 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 1 of 1 · See all- K090663Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912935 | Ams Malleable 600 and 600M Penile Prosthesis | American Medical Systems, Inc. | 1992 | — |
| 0 (this device) | K082006 | Ams Spectra Concealable Penile Prosthesis | American Medical Systems, Inc. | 2008 | — |
| +1 | K090663 | Ams Spectra Concealable Penile Prosthesis | American Medical Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 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? (3)
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 |
|---|---|---|---|
| * | K953640 | Duna II Penile ProsthesisSummary page 1…(special controls) Product Codes 78 FAE (penile prosthesis) Predicate Devices DURA LI® Penile Prosthesis (K953640) AMS 600MTM Malleable Penile Prosthesis (K912935)… | 1995 |
| * | K912935 | Ams Malleable 600 and 600M Penile ProsthesisSummary page 1…Predicate Devices DURA LI® Penile Prosthesis (K953640) AMS 600MTM Malleable Penile Prosthesis (K912935) AMvS 650TM Malleable Penile Prosthesis (K(951716) Indications for… | 1992 |
| * | K951716 | Ams 650 Mallerable Peniel ProsthesisSummary page 1…AMS 600MTM Malleable Penile Prosthesis (K912935) AMvS 650TM Malleable Penile Prosthesis (K(951716) Indications for Use The AMS SpectraTm Concealable Penile Prosthesis is a sterile, non-… | 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 |
|---|---|---|---|
| K090663 | Ams Spectra Concealable Penile Prosthesis | 2009 | 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?
How does its category compare?
All FAE devicesFAE Prosthesis, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 | — |
What is it indicated for?
The AMS Spectra TM Concealable Penile Prosthesis is a sterile, non-pyrogenic, single-use implant that is intended for use in the treatment of chronic, organic, erectile dysfunction (impotence) in.men who are determined to be suitable candidates for implantation surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082006: Ams Spectra Concealable Penile Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082006
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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