Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medevice, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
172 daysmedian FDA review time
408 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K072550 | SIGHTSURE OPERATIONAL INDICATOR, MODEL SS301 | Medevice, Inc. | 2007-12-07 | 88 | 0 |
| K920638 | BIO-MATE PIC CATHETER | Medevice, Inc. | 1993-03-26 | 408 | 0 |
| K912856 | MEDE-FLO I.V. EXTENSION SET | Medevice, Inc. | 1991-12-17 | 172 | 0 |
| K901129 | BIO-MATE(TM) PEDIATRIC EPIDURAL CATHETER | Medevice, Inc. | 1990-03-30 | 18 | 0 |
| K884969 | BIO-MATE(TM) EPIDURAL CATHETER | Medevice, Inc. | 1989-06-23 | 205 | 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