Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Fraass Survival Systems, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
29 daysmedian FDA review time
87 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1991-08-02 | 87 | 0 |
| K871437 | SURVIVAL KIT, INDIVIDUAL | Fraass Survival Systems, Inc. | 1987-07-09 | 87 | 0 |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | Fraass Survival Systems, Inc. | 1987-07-09 | 87 | 0 |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | Fraass Survival Systems, Inc. | 1987-07-09 | 87 | 0 |
| K871917 | FRASTEC DRY GAUZE BANDAGE | Fraass Survival Systems, Inc. | 1987-06-16 | 29 | 0 |
| K871916 | FRASTEC DRY BURN DRESSING | Fraass Survival Systems, Inc. | 1987-06-16 | 29 | 0 |
| K871376 | FIRST AID KIT, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1987-06-04 | 58 | 0 |
| K871501 | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | Fraass Survival Systems, Inc. | 1987-06-02 | 46 | 0 |
| K871457 | FIRST AID KIT, EYE DRESSING | Fraass Survival Systems, Inc. | 1987-05-29 | 46 | 0 |
| K871438 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 | Fraass Survival Systems, Inc. | 1987-05-06 | 23 | 0 |
| K870240 | COMPRESS AND SKULLCAP, HEAD DRESSING | Fraass Survival Systems, Inc. | 1987-02-20 | 30 | 0 |
| K870241 | COMPRESS AND BANDAGE, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1987-02-06 | 16 | 0 |
| K870185 | BANDAGE, GAUZE (NONABSOR. GAUZE FOR EXTERNAL USE) | Fraass Survival Systems, Inc. | 1987-02-06 | 21 | 0 |
| K870239 | DRESSING, BURN, 24 BY 36 INCHES | Fraass Survival Systems, Inc. | 1987-02-06 | 16 | 0 |
| K870184 | BANDAGE, GAUZE, FINE MESH, 3 BY 8 INCHES | Fraass Survival Systems, Inc. | 1987-02-06 | 21 | 0 |
| K864011 | EXU-DRY BURN/TRAUMA DRESSING, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1986-11-22 | 38 | 0 |
| K864023 | EYE PAD, COTTON, GAUZE COVERED | Fraass Survival Systems, Inc. | 1986-11-07 | 23 | 0 |
| K864175 | SPONGE, SURGICAL, GAUZE, COMPRESSED 2 BY 2 INCHES | Fraass Survival Systems, Inc. | 1986-11-05 | 12 | 0 |
| K863932 | GAUZE, ABSORBENT, STERILE, COMPRESSED | Fraass Survival Systems, Inc. | 1986-10-24 | 16 | 0 |
| K863714 | BANDAGE, GAUZE, SIX-PLY, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1986-10-14 | 21 | 0 |
| K863713 | BANDAGE, GAUZE, TWO-PLY, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1986-10-14 | 21 | 0 |
| K863850 | DRESSING, FIRST AID, FIELD, VARIOUS SIZES | Fraass Survival Systems, Inc. | 1986-10-14 | 12 | 0 |
| K840498 | EXU-DRY BURN-TRAUMA DRESSING-VARIOUS | Fraass Survival Systems, Inc. | 1984-05-30 | 114 | 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