Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
PAH — Predicate Candidate Screening
20 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
373 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242473 | Altis Single Incision Sling System (519650); Aris Transobtur | Coloplast Corp. | 2024-10-18 | 59 | 0 |
| K221874 | Altis Single Incision Sling System | Coloplast A/S | 2023-02-15 | 232 | 0 |
| K191416 | Desara One Single Incision Sling System, 1 Pack ; Desara One | Caldera Medical, Inc. | 2020-02-07 | 255 | 0 |
| K121562 | ALTIS SINGLE INCISION CLING SYSTEM | Coloplast A/S | 2012-11-05 | 160 | 0 |
| K123179 | AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING | C.R. Bard, Inc. | 2012-11-02 | 24 | 0 |
| K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM | American Medical Systems | 2012-09-07 | 95 | 1 |
| K110420 | OPHIRA MINI SLING SYSTEM | Promedon S.A | 2012-05-08 | 449 | 0 |
| K103418 | DESARA MINI | Caldera Medical, Inc. | 2011-11-30 | 373 | 0 |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, | American Medical Systems, Inc. | 2010-06-07 | 77 | 0 |
| K092607 | AJUST ADJUSTABLE SINGLE INCISION SLING | C.R. Bard, Inc. | 2009-11-20 | 87 | 0 |
| K091180 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2009-07-14 | 82 | 0 |
| K081275 | BOSTON SCIENTIFIC SURGICAL MESH | Boston Scientific Corp | 2008-08-27 | 114 | 0 |
| K073646 | MINITAPE URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-02-25 | 61 | 0 |
| K073703 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2008-01-30 | 30 | 0 |
| K071902 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2007-08-24 | 45 | 0 |
| K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | American Medical Systems, Inc. | 2007-03-01 | 52 | 0 |
| K063136 | NEEDLELESS SLING | Specialities Remeex International, S.L. | 2006-12-19 | 64 | 0 |
| K052401 | GYNECARE TVT SECUR SYSTEM | ETHICON, Inc. | 2005-11-28 | 88 | 0 |
| K023898 | GYNE IDEAS MINITAPE RP DEVICE | Gyne Ideas , Ltd. | 2003-06-18 | 208 | 0 |
| K020652 | HERNIAMESH T-SLING | Herniamesh | 2002-05-15 | 76 | 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