Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ascent Healthcare Solutions · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
270 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K111600 | REPROCESSED HAND ACTIVATE SEALER/DIVIDER | Ascent Healthcare Solutions | 2011-11-15 | 160 | 0 |
| K110189 | REPROCESSED ELECTROSURGICAL INSTRUMENT | Ascent Healthcare Solutions | 2011-07-18 | 175 | 0 |
| K100909 | REPROCESSED COMPRESSION SLEEVES | Ascent Healthcare Solutions | 2010-07-23 | 113 | 1 |
| K100254 | REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CA | Ascent Healthcare Solutions | 2010-05-28 | 120 | 26 |
| K100537 | REPROCESSED ULTRASONIC CURVED SHEARS WITH TORQUE WRENCH AND | Ascent Healthcare Solutions | 2010-05-12 | 76 | 0 |
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT | Ascent Healthcare Solutions | 2010-03-19 | 66 | 1 |
| K093702 | REPROCESSED ULTRASONIC COAGULATING SHEARS | Ascent Healthcare Solutions | 2010-03-04 | 93 | 0 |
| K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR | Ascent Healthcare Solutions | 2009-10-21 | 75 | 0 |
| K090323 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Ascent Healthcare Solutions | 2009-04-01 | 51 | 0 |
| K082023 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Ascent Healthcare Solutions | 2008-09-16 | 62 | 0 |
| K081238 | REPROCESSED MASIMO PULSE OXIMETER SENSORS | Ascent Healthcare Solutions | 2008-07-29 | 89 | 0 |
| K081329 | REPROCESSED ELECTROPHYSIOLOGY CATHETERS | Ascent Healthcare Solutions | 2008-07-09 | 58 | 0 |
| 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 |
| K070036 | REPROCESSED MEDTRONIC CARDIAC STABILIZATION AND POSITIONING | Ascent Healthcare Solutions | 2007-08-17 | 226 | 0 |
| K070034 | REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DE | Ascent Healthcare Solutions | 2007-08-17 | 226 | 0 |
| K062525 | REPROCESSED LIGASURE VESSEL SEALER/DIVIDER | Ascent Healthcare Solutions | 2007-05-16 | 261 | 0 |
| K063076 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | Ascent Healthcare Solutions | 2007-03-29 | 174 | 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 |
| K061759 | REPROCESSED EXTERNAL FIXATION DEVICE | Ascent Healthcare Solutions | 2006-09-05 | 75 | 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