Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OTO — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
97 daysmedian FDA review time
235 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K171271 | Polyform Synthetic Mesh | Boston Scientific Corporation | 2017-12-15 | 228 | 0 |
| K150023 | Vertessa Lite Y-Mesh | Caldera Medical, Inc. | 2015-04-06 | 90 | 0 |
| K150016 | Vertessa Lite | Caldera Medical, Inc. | 2015-04-06 | 91 | 0 |
| K140116 | RESTORELLE Y CONTOUR MESH | Coloplast A/S | 2014-02-12 | 27 | 0 |
| K132061 | RESTORELLE M, RESTORELLE XL | Coloplast Corp. | 2013-08-02 | 30 | 0 |
| K123028 | VERTESSA LITE 10 X20CM, VERTESSA LITE 11 X 30CM, VERTESSA LI | Caldera Medical, Inc. | 2013-04-25 | 209 | 0 |
| K123914 | RESTORELLE Y CONTOUR | Coloplast A/S | 2013-03-05 | 76 | 0 |
| K123337 | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM | Caldera Medical | 2013-02-21 | 113 | 0 |
| K122794 | UPSYLON Y MESH | Boston Scientific Corp | 2012-12-18 | 97 | 0 |
| K122968 | NOVASILK MESH QTY 1 MODEL 93-6014, NOVASILK MESH QTY 3 MODEL | Coloplast Corp. | 2012-12-18 | 84 | 0 |
| K122440 | RESTORELLE L | Coloplast Corp. | 2012-11-19 | 101 | 1 |
| K121805 | AMS LARGE PORE POLYPROPHLENE MESH | American Medical Systems | 2012-10-16 | 119 | 0 |
| K113205 | ARTISYN Y-SHAPED MESH | ETHICON, Inc. | 2012-06-11 | 224 | 0 |
| K112322 | RESTORELLE POLYPROPYLENE Y MESH | Coloplast A/S | 2012-05-17 | 279 | 0 |
| K120327 | VERTESSA | Caldera Medical, Inc. | 2012-05-10 | 98 | 0 |
| K101722 | ALYTE Y-MESH GRAFT | C.R. Bard, Inc. | 2011-04-01 | 287 | 0 |
| K090739 | BARD SACROCOLPOPEXY GRAFT | C.R. Bard, Inc. | 2009-11-10 | 235 | 0 |
| K053361 | MODIFICATION TO: MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2006-02-06 | 66 | 1 |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | 2005-08-03 | 58 | 0 |
| K051245 | POLYFORM SYNTHETIC MESH | Proxy Biomedical , Ltd. | 2005-06-17 | 32 | 0 |
| K041632 | MINIMESH POLYPROPYLENE MESH | Mpathy Medical Devices, Ltd. | 2004-11-17 | 154 | 1 |
| K013718 | GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETI | Gynecare, A Div. of Ethicon, Inc. | 2002-01-08 | 61 | 1 |
| K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 | American Medical Systems, Inc. | 2001-04-09 | 12 | 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