Fraass Survival Systems, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “Fraass Survival Systems, Inc.” (first 1984, latest 1991), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 29 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 8 | 8 |
| NAD | Dressing, Wound, Occlusive | 4 | 4 |
| LRR | First Aid Kit With Drug | 3 | 3 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
| LRO | General Surgery Tray | 2 | 2 |
| EXR | Urinometer, Mechanical | 1 | 1 |
| KDD | Kit, Surgical Instrument, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Fraass Survival Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K912022 | FRASTEC DRYNET, BRIDAL VEIL, VARIOUS SIZES | NAD | 1991-08-02 | 87 |
| K871458 | SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW | KDD | 1987-07-09 | 87 |
| K871437 | SURVIVAL KIT, INDIVIDUAL | LRO | 1987-07-09 | 87 |
| K871434 | MEDICAL PACKET, INDIVIDUAL SURVIVAL KIT, AIRMAN'S | LRO | 1987-07-09 | 87 |
| K871917 | FRASTEC DRY GAUZE BANDAGE | EFQ | 1987-06-16 | 29 |
| K871916 | FRASTEC DRY BURN DRESSING | EFQ | 1987-06-16 | 29 |
| K871376 | FIRST AID KIT, VARIOUS SIZES | LRR | 1987-06-04 | 58 |
| K871501 | KIT, FIRST AID, GENERAL PURPOSE, RIGID CASE | LRR | 1987-06-02 | 46 |
| K871457 | FIRST AID KIT, EYE DRESSING | LRR | 1987-05-29 | 46 |
| K871438 | BANDAGE, MUSLIN, COMPRESSED, CAMOUFLAGED 37X37X52 | EFQ | 1987-05-06 | 23 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Fraass Survival Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Fraass Survival Systems, Inc.?
FDA lists 23 510(k) clearances under the applicant name “Fraass Survival Systems, Inc.” (first 1984, latest 1991), across 8 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Fraass Survival Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fraass Survival Systems, Inc. is 29 days.
Which FDA product codes appear under Fraass Survival Systems, Inc.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 8); NAD (Dressing, Wound, Occlusive, 4); LRR (First Aid Kit With Drug, 3).
Next steps
- See all 23 Fraass Survival Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Fraass Survival Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.