Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Medical Systems · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
95 daysmedian FDA review time
219 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS | American Medical Systems | 2014-06-20 | 94 | 2 |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | American Medical Systems | 2013-12-05 | 219 | 1 |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | American Medical Systems | 2012-10-16 | 119 | 0 |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | American Medical Systems | 2012-09-07 | 95 | 1 |
| K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH | American Medical Systems | 2012-07-20 | 49 | 0 |
| K120870 | GREENLIGHT MOXY FIBER OPTIC | American Medical Systems | 2012-06-15 | 85 | 0 |
| K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICA | American Medical Systems | 2011-07-01 | 71 | 0 |
| K100746 | FIBER ONE | American Medical Systems | 2010-06-11 | 87 | 1 |
| K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, | American Medical Systems | 2008-12-04 | 107 | 0 |
| K081710 | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE | American Medical Systems | 2008-10-15 | 120 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda