Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Certified Safety Mfg., Inc. · Predicate Candidate Screening
17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
286 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K960587 | CPROTECTOR 2000 | Certified Safety Mfg., Inc. | 1997-07-21 | 525 | 0 |
| K960615 | GAUZE COMPRESS | Certified Safety Mfg., Inc. | 1996-11-25 | 286 | 0 |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | Certified Safety Mfg., Inc. | 1996-05-06 | 83 | 0 |
| K953102 | BLOODBORNE PATHOGEN KIT | Certified Safety Mfg., Inc. | 1995-12-11 | 161 | 0 |
| K946338 | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING | Certified Safety Mfg., Inc. | 1995-03-29 | 90 | 0 |
| K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE | Certified Safety Mfg., Inc. | 1995-03-22 | 160 | 0 |
| K945004 | 2, 3 & 4 BANDADGE COMPRESS | Certified Safety Mfg., Inc. | 1995-03-22 | 160 | 0 |
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | Certified Safety Mfg., Inc. | 1994-10-03 | 257 | 0 |
| K941311 | FIRST AID/TRUMA KIT | Certified Safety Mfg., Inc. | 1994-06-14 | 88 | 0 |
| K940358 | X-LARGE MULTI-FUNCTION TRAUMA DRESSING | Certified Safety Mfg., Inc. | 1994-03-23 | 57 | 0 |
| K940333 | EYE PAD | Certified Safety Mfg., Inc. | 1994-03-07 | 41 | 0 |
| K940336 | CERTI HEAT INSTANT HEAT COMPRESS | Certified Safety Mfg., Inc. | 1994-03-07 | 41 | 0 |
| K940348 | TRAUMA PAD 5 X 9 | Certified Safety Mfg., Inc. | 1994-02-25 | 31 | 0 |
| K940345 | TRIANGULAR BANDAGE | Certified Safety Mfg., Inc. | 1994-02-25 | 31 | 0 |
| K940344 | 8 X 10 NON-STICK PAD | Certified Safety Mfg., Inc. | 1994-02-25 | 31 | 0 |
| K940351 | EXTRA LARGE COMPRESS DRESSING | Certified Safety Mfg., Inc. | 1994-02-25 | 31 | 0 |
| K934821 | CPROTECTOR | Certified Safety Mfg., Inc. | 1994-01-06 | 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