Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OTN — Predicate Candidate Screening
65 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
159 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231549 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ult | Boston Scientific Corporation | 2023-06-29 | 30 | 0 |
| K222293 | ArcSP Suprapubic Sling System | Urocure, LLC | 2022-09-21 | 51 | 0 |
| K222468 | ArcTO Transobturator Sling System | Urocure, LLC | 2022-09-15 | 30 | 0 |
| K211975 | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desar | Caldera Medical, Inc. | 2021-11-10 | 138 | 0 |
| K211223 | Advantage Ultra System, Advantage Fit Ultra System, Lynx Ult | Boston Scientific Corporation | 2021-07-21 | 89 | 0 |
| K210087 | Athena Surgical RMUS System | Athena Surgical, LLC | 2021-04-12 | 89 | 0 |
| K201686 | GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides Sy | ETHICON, Inc. | 2020-09-17 | 87 | 0 |
| K183134 | ArcTV Transvaginal Sling System | Urocure, LLC | 2019-02-07 | 86 | 0 |
| K162201 | Desara TV, Desara Blue TV | Caldera Medical, Inc. | 2017-01-11 | 159 | 0 |
| K140843 | DESARA BLUE OV, DESARA BLUE SS | Caldera Medical | 2014-07-01 | 90 | 0 |
| K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS | American Medical Systems | 2013-12-05 | 219 | 1 |
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | American Medical Systems, Inc. | 2013-11-20 | 86 | 0 |
| K132069 | DESARA MESH, DESARA BLUE | Caldera Medical, Inc. | 2013-09-23 | 82 | 0 |
| K132054 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2013-08-23 | 51 | 0 |
| K121928 | DESARA SL | Caldera Medical, Inc. | 2013-02-19 | 232 | 0 |
| K121754 | BLUE SUI SLING | Boston Scientific Corp | 2012-10-10 | 118 | 0 |
| K103022 | KIM | Neomedic International S.L. | 2011-12-20 | 434 | 0 |
| K112609 | DESARA MESH | Caldera Medical, Inc. | 2011-09-30 | 22 | 0 |
| K111219 | GMD UNIVERSAL URINARY INCONTINENCE SLING | Generic Medical Device, Inc. | 2011-06-30 | 59 | 0 |
| K111233 | SUPRIS RETROPUBIC SLING SYSTEM | Coloplast A/S | 2011-06-24 | 53 | 0 |
| K100936 | GYNECARE TVT ABBREVO CONTINENCE SYSTEM | ETHICON, Inc. | 2010-07-01 | 87 | 0 |
| K101440 | GMD UNIVERSAL URINARY INCONTINENCE SLING, MODEL 1012 | Generic Medical Devices, Inc. | 2010-06-18 | 25 | 0 |
| K101169 | DESARA MESH MODEL: CAL-DS01 | Caldera Medical, Inc. | 2010-05-20 | 24 | 0 |
| K093747 | ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS | C.R. Bard, Inc. | 2010-05-07 | 154 | 0 |
| K100485 | GYNECARE TVT EXACT CONTINENCE SYSTEM | ETHICON, Inc. | 2010-03-16 | 25 | 0 |
| K092203 | OMNISURE URETHRAL SLING, MODEL OTK52 | Mpathy Medical Devices, Ltd. | 2009-08-12 | 21 | 0 |
| K083471 | GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020 | Generic Medical Device, Inc. | 2009-03-03 | 99 | 2 |
| K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | American Medical Systems, Inc. | 2008-09-17 | 100 | 0 |
| K072456 | DESARA MESH SLING, MODEL CAL-DS01 | Caldera Medical, Inc. | 2008-05-08 | 251 | 0 |
| K073647 | MINITAPE EXTRA URETHRAL SLING | Mpathy Medical Devices, Ltd. | 2008-03-03 | 68 | 0 |
| K070073 | ALIGN URETHRAL SUPPORT SYSTEM | C.R. Bard, Inc. | 2007-03-21 | 72 | 0 |
| K063713 | AMS SMART SLING SYSTEM | American Medical Systems, Inc. | 2007-02-22 | 70 | 0 |
| K050516 | T-SLING | Herniamesh S.R.L. | 2006-02-03 | 339 | 0 |
| K053296 | MENTOR ARIS SUPRAPUBIC SURGICAL KIT | Mentor Corporation | 2005-12-15 | 20 | 0 |
| K052175 | I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, | Uroplasty, Inc. | 2005-10-17 | 68 | 0 |
| K051533 | I-STOP | Cl Medical | 2005-08-11 | 63 | 0 |
| K051530 | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFAS | American Medical Systems, Inc. | 2005-07-08 | 29 | 1 |
| K050148 | MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT | Mentor Corporation | 2005-03-09 | 44 | 0 |
| K042592 | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBI | American Medical Systems, Inc. | 2004-12-14 | 82 | 0 |
| K042851 | MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT | Mentor Corp. | 2004-11-09 | 25 | 0 |
| K041948 | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS | American Medical Systems, Inc. | 2004-08-11 | 22 | 0 |
| K041176 | URETEX TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM | Sofradim Production | 2004-05-17 | 12 | 0 |
| K040787 | MODIFICATION TO SURGICAL MESH POLYMERIC | Boston Scientific | 2004-04-14 | 16 | 0 |
| K040538 | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851 | American Medical Systems, Inc. | 2004-03-17 | 15 | 0 |
| K033310 | REMEEX SYSTEM FOR URINARY INCONTINENCE | Specialities Remeex International, S.L. | 2004-01-15 | 93 | 0 |
| K033691 | SAFYRE VS AND SAFYRE T | Promedon | 2003-12-19 | 25 | 0 |
| K033568 | GYNECARE TVT OBTURATOR SYSTEM | ETHICON, Inc. | 2003-12-08 | 26 | 0 |
| K031767 | MENTOR OBTAPE TRANS-OBTURATOR TAPE | Mentor Corp. | 2003-07-17 | 38 | 0 |
| K030123 | BIOARC SP SLING KIT | American Medical Systems, Inc. | 2003-02-06 | 23 | 0 |
| K023516 | MONARC SLING SYSTEM | American Medical Systems, Inc. | 2002-11-19 | 29 | 1 |
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