510(k) Report

510(k) · Cleared

Cleared

Ams Malleable 600 and 600M Penile Prosthesis

K912935510(k) TraditionalCleared Mar 18, 1992257-day reviewClass II21 CFR 876.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Medical Systems, Inc. · FAE Prosthesis, Penile

Cleared on Mar 18, 1992 after a 257-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
Mar 18, 1992
Review
257 days
Class
Class II
Product code
FAE
Recalls
None
Predicates
0

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

Descendants, by year cleared 2008: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK912935 Ams Malleable 600 and 600M Penile ProsthesisAmerican Medical Systems, Inc. · 1992
  2. Descendant · cites it directly · 1 of its ownK082006 Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2008
  3. Descendant · 2 generations on · 0 of its ownK090663 Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K082006Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2008 · cites it directly1descendant
  • K090663Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912935Ams Malleable 600 and 600M Penile ProsthesisAmerican Medical Systems, Inc.1992—
+1K082006Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.2008—
+2K090663Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
FIG. 1 — Lineage of K912935, 1992–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

NumberDeviceApplicantDecidedDescendants
K082006Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc.20081

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, K082006 (American Medical Systems, Inc., 2008) has gone furthest, with 1 descendant of its own.

How does its category compare?

All FAE devices

FAE Prosthesis, Penile: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FAE

2in 2019

2008: 12009: 12019: 2
2007high 2 (2019) · low 0 (2007)2026

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

2007: 2
2007high 2 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FAE

195in 2025

2007: 32008: 52009: 52010: 272011: 872012: 972013: 1082014: 752015: 982016: 1042017: 1232018: 1272019: 2212020: 1632021: 1672022: 1682023: 1602024: 1872025: 195
2007high 221 (2019) · low 3 (2007)2025

MAUDE reports naming product code FAE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—23
20081—05
20091—05
20100—027
20110—087
20120—097
20130—0108
20140—075
20150—098
20160—0104
20170—0123
20180—0127
20192—0221
20200—0163
20210—0167
20220—0168
20230—0160
20240—0187
20250—0195
20260—0—

More from American Medical Systems, Inc.

75 FDA decisions under this applicant name. See the company

  • K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
  • K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc. · 20091 recall
  • K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2009

Recent decisions in FAE

The FAE category page

  • K183619Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis…Boston Scientific Corporation · 2019
  • K181673Rigi10 Malleable Penile ProsthesisRigicon, Inc. · 2019
  • K090663Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2009
  • K082006Ams Spectra Concealable Penile ProsthesisAmerican Medical Systems, Inc. · 2008
  • K040959Mentor Genesis Penile ProsthesisMentor Corp. · 20041 recall

https://510kreport.com/device/K912935 · printed Nov 4, 2026

Cite this page

510(k) Report. “K912935: Ams Malleable 600 and 600M 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/K912935

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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