Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dynarex Corp. — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
213 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052743 | DYNAREX CPR SHIELD WITH ONE WAY VALVE AND BARRIER FILTER, MO | Dynarex Corp. | 2005-12-22 | 83 | 1 |
| K052314 | DYNAREX VAGINAL SPECULA 4900, MODELS 4911-SMALL, 4912-MEDIUM | Dynarex Corp. | 2005-11-09 | 76 | 0 |
| K012816 | DYNAREX IODOFORM PACKING STRIPS, MODELS 3411, 3412, 3413, 34 | Dynarex Corp. | 2002-10-17 | 421 | 0 |
| K012957 | TOWEL DRAPE, MODELS 4409, 4410 | Dynarex Corp. | 2002-03-06 | 183 | 0 |
| K012917 | DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B | Dynarex Corp. | 2001-11-28 | 90 | 0 |
| K991694 | DYNAREX DRAIN SPONGE | Dynarex Corp. | 1999-07-15 | 58 | 0 |
| K991695 | DYNAREX NON-WOVEN SPONGE | Dynarex Corp. | 1999-07-15 | 58 | 0 |
| K983348 | DYNAREX TRACHEOSTOMY SPONGE | Dynarex Corp. | 1998-12-11 | 79 | 0 |
| K960388 | DYNAREX NON-WOVEN SPONGE | Dynarex Corp. | 1996-04-01 | 66 | 0 |
| K951660 | DYNAREX GAUZE SPONGE | Dynarex Corp. | 1995-05-09 | 29 | 0 |
| K933308 | DYNAREX GAUZE SPONGE OR PADS | Dynarex Corp. | 1993-12-22 | 168 | 0 |
| K922843 | DYNAREX SUCTION CATHETERS & KITS | Dynarex Corp. | 1993-01-11 | 213 | 0 |
| K894686 | POWDER-FREE VINYL EXAMINATION GLOVES | Dynarex Corp. | 1990-01-26 | 185 | 0 |
| K893334 | PREPOWDERED VINYL EXAM GLOVES | Dynarex Corp. | 1989-08-15 | 117 | 0 |
| K891586 | ORAL AIRWAY | Dynarex Corp. | 1989-05-11 | 52 | 0 |
| K882567 | SKINCOTE | Dynarex Corp. | 1988-10-05 | 105 | 0 |
| K855130 | TRACHEOSTOMY CARE KIT | Dynarex Corp. | 1986-03-04 | 71 | 0 |
| K855132 | SHAVE PREP TRAY | Dynarex Corp. | 1986-01-24 | 32 | 0 |
| K855131 | SUTURE REMOVAL KIT | Dynarex Corp. | 1986-01-13 | 21 | 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