Certified Safety Mfg., Inc.: FDA clearances and approvals
Certified Safety Mfg., Inc. has 17 FDA 510(k) clearances (first 1994, latest 1997), across 7 product codes in 4 review panels. Median 510(k) review time: 88 days. openFDA lists 3 product recalls by a recalling firm named Certified Safety Mfg., Inc.
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 |
| CBP | Valve, Non-Rebreathing | 2 | 2 |
| IMD | Pack, Hot Or Cold, Disposable | 2 | 2 |
| LRR | First Aid Kit With Drug | 2 | 2 |
| FXX | Mask, Surgical | 1 | 1 |
| HMP | Pad, Eye | 1 | 1 |
| MGP | Dressing, Wound And Burn, Occlusive | 1 | 1 |
Review panels
Most recent Certified Safety Mfg., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960587 | CPROTECTOR 2000 | CBP | 1997-07-21 | 525 |
| K960615 | GAUZE COMPRESS | EFQ | 1996-11-25 | 286 |
| K960624 | CERTI COOL INSTANT COLD COMPRESS | IMD | 1996-05-06 | 83 |
| K953102 | BLOODBORNE PATHOGEN KIT | FXX | 1995-12-11 | 161 |
| K946338 | CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING | MGP | 1995-03-29 | 90 |
| K945004 | 2, 3 & 4 BANDADGE COMPRESS | EFQ | 1995-03-22 | 160 |
| K945002 | 1X6YD, 2X6YD, 4X6YD ROLL BANDAGE | EFQ | 1995-03-22 | 160 |
| K940249 | CERTIBURN BURN/TRAUMA FACE DRESSING /TOWEL DRESSING | LRR | 1994-10-03 | 257 |
| K941311 | FIRST AID/TRUMA KIT | LRR | 1994-06-14 | 88 |
| K940358 | X-LARGE MULTI-FUNCTION TRAUMA DRESSING | EFQ | 1994-03-23 | 57 |
7 earlier clearances. See the full list in Caduvo.
Recalls
3 product recalls in 3 recall events; 1 initiated in the last five years. Most recent: 2022-04-05.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Certified Safety Mfg., Inc. have?
Certified Safety Mfg., Inc. has 17 FDA 510(k) clearances (first 1994, latest 1997), across 7 product codes in 4 review panels.
How long does FDA take to clear Certified Safety Mfg., Inc.'s 510(k)s?
The median time from FDA receipt to decision across Certified Safety Mfg., Inc.'s cleared 510(k)s is 88 days.
What devices does Certified Safety Mfg., Inc. make?
Its most frequent FDA product codes are EFQ (Gauze/Sponge, Internal, 8); CBP (Valve, Non-Rebreathing, 2); IMD (Pack, Hot Or Cold, Disposable, 2).
Has Certified Safety Mfg., Inc. had device recalls?
openFDA lists 3 product recalls in 3 recall events by a recalling firm whose name matches Certified Safety Mfg., Inc; the most recent began 2022-04-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 17 Certified Safety Mfg., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Certified Safety Mfg., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.