Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microtek Medical, Inc. — Predicate Candidate Screening
24 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
209 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K110358 | VENODYNE V810 | Microtek Medical, Inc. | 2011-05-05 | 87 | 0 |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | Microtek Medical, Inc. | 2011-02-23 | 140 | 0 |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | Microtek Medical, Inc. | 2007-01-25 | 120 | 0 |
| K060200 | MICROTEK MEDICAL WARMING DRAPE | Microtek Medical, Inc. | 2006-05-31 | 125 | 0 |
| K050322 | MICROTEK EQUIPMENT DRAPES | Microtek Medical, Inc. | 2005-05-17 | 97 | 17 |
| K022903 | CHILLBUSTER | Microtek Medical, Inc. | 2002-11-27 | 85 | 0 |
| K020956 | VIVOSONIC DIANOSTIC ULTRASOUND IMAGING COUPLING MEDIA | Microtek Medical, Inc. | 2002-05-16 | 52 | 0 |
| K011318 | VENODYNE DVT ADVANTAGE PLUS | Microtek Medical, Inc. | 2001-10-25 | 177 | 0 |
| K001802 | VENODYNE DVT ADVANTAGE MODEL 610 | Microtek Medical, Inc. | 2001-01-09 | 209 | 0 |
| K950906 | LESINSKI SURGICAL EAR DRESSING | Microtek Medical, Inc. | 1995-06-22 | 114 | 0 |
| K925610 | FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN | Microtek Medical, Inc. | 1994-11-18 | 743 | 0 |
| K874535 | MICROTEK MINI-MAX DRILL SYSTEM | Microtek Medical, Inc. | 1987-11-23 | 20 | 0 |
| K862496 | MICROTEK INTRANASAL SPLINT | Microtek Medical, Inc. | 1986-07-14 | 13 | 0 |
| K862497 | MICROTEK SEPTAL BUTTON | Microtek Medical, Inc. | 1986-07-14 | 13 | 0 |
| K860460 | MICROTEK STAINLESS STEEL PISTON | Microtek Medical, Inc. | 1986-07-11 | 155 | 0 |
| K844061 | MICROTEK IRRIGATION SYSTEM | Microtek Medical, Inc. | 1985-05-21 | 215 | 0 |
| K833608 | GOLD ALLIGATOR FORCEPS | Microtek Medical, Inc. | 1984-01-11 | 91 | 0 |
| K833607 | MCGEE FORCEPS | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K833606 | IMPLANT MEASURING GAUGE | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K833605 | CUPPED FORCEPS | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K833602 | ROLLER KNIFE-TRANSVERSE -SAGITTAL | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K833601 | ANTRUM & ATTIC MIRROR | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K833604 | ADJUSTABLE FORK RETRACTOR | Microtek Medical, Inc. | 1984-01-03 | 83 | 0 |
| K833603 | SCISSORS SHEA BELLUCC | Microtek Medical, Inc. | 1984-01-03 | 83 | 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