Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NLM — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
131 daysmedian FDA review time
298 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | Stryker Sustainability Solutions | 2020-07-31 | 56 | 0 |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Sut | Surgical Instrument Service and Savings, Inc. | 2019-04-15 | 192 | 0 |
| K172097 | Reprocessed Ethicon Bladeless Trocars; Reprocessed Ethicon U | Renovo, Inc. | 2017-10-06 | 87 | 0 |
| K172093 | Reprocessed Covidien Trocar | Renovo, Inc. | 2017-10-05 | 86 | 0 |
| K160740 | Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVI | Surgical Instrument Service and Savings, Inc. | 2016-05-06 | 50 | 0 |
| K153258 | Medline ReNewal Reprocessed Versaport V2 Bladeless Optical T | Surgical Instrument Service and Savings (Dba Medline Renewal | 2016-04-05 | 147 | 0 |
| K133414 | REPROCESSED CLOSURE SYSTEM | Sterilmed, Inc. | 2014-01-22 | 76 | 1 |
| K132629 | REPROCESSED DILATING TIP TROCARS | Stryker Sustainability Solutions | 2013-12-31 | 131 | 0 |
| K121240 | REPROCESSED ENDOSCOPIC TROCARS | Sterilmed, Inc. | 2012-06-11 | 48 | 0 |
| K111002 | REPROCESSED ENDOSCOPIC TROCARS | Sterilmed, Inc. | 2011-07-18 | 98 | 0 |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | Ascent Healthcare Solutions | 2010-03-19 | 66 | 1 |
| K063788 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | Ascent Healthcare Solutions | 2007-10-15 | 298 | 3 |
| K070059 | REPROCESSED TROCARS | Ascent Healthcare Solutions | 2007-10-02 | 270 | 0 |
| K060676 | NES REPROCESSED ENDOSCOPIC TROCAR | Northeast Scientific, Inc. | 2007-09-07 | 542 | 0 |
| K062497 | REPROCESSED TROCARS | Ascent Healthcare Solutions | 2007-01-31 | 159 | 1 |
| K053585 | VANGUARD REPROCESSED SUTURE PASSER | Ascent Healthcare Solutions | 2006-10-11 | 292 | 1 |
| K052299 | REPROCESSED ENDOSCOPIC TROCAR | Sterilmed, Inc. | 2006-05-23 | 272 | 0 |
| K043592 | REPROCESSED ENDOSCOPIC TROCAR | Sterilmed, Inc. | 2005-05-23 | 145 | 0 |
| K043253 | VANGUARD REPROCESSED DILATING TIP AND BLUNT TROCARS | Vanguard Medical Concepts, Inc. | 2005-04-08 | 135 | 1 |
| K043594 | VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCA | Vanguard Medical Concepts, Inc. | 2005-03-31 | 92 | 1 |
| K024015 | REPROCESSED ENDOSCOPIC TROCARS AND CANNULAS | Alliance Medical Corp. | 2003-03-04 | 90 | 0 |
| K012644 | REPROCESSED TROCARS AND CANNULAS | Surgical Instruments Service and Savings, Inc. | 2002-07-29 | 350 | 1 |
| K012578 | REPROCESSED ENDOSCOPIC TROCAR | Sterilmed, Inc. | 2001-11-07 | 90 | 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