American Safety Equipment Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “American Safety Equipment Corp.” (first 1976, latest 1980), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 15 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 |
|---|---|---|---|
| DZH | Saw, Bone, Ac-Powered | 2 | 2 |
| DZA | Drill, Dental, Intraoral | 1 | 1 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 1 | 1 |
| EMM | Chisel, Osteotome, Surgical | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KPA | Slide Stainer, Automated | 1 | 1 |
Review panels
- Dental (5)
- Orthopedic (1)
- Pathology (1)
Most recent American Safety Equipment Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K801010 | KIRSCHNER WIRE | HSB | 1980-05-20 | 22 |
| K771699 | CARA-STAIN MODEL 3000 | KPA | 1977-09-13 | 7 |
| K760960 | SURGICAL WIRE DRIVER | DZJ | 1976-11-19 | 18 |
| K760956 | SURGICAL MICRO DRILL | DZA | 1976-11-19 | 18 |
| K760958 | SURGICAL OSCILLATING SAW | DZH | 1976-11-16 | 15 |
| K760959 | SURGICAL CHISEL | EMM | 1976-11-15 | 14 |
| K760957 | SURGICAL RECIPROCATING SAW | DZH | 1976-11-15 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named American Safety Equipment Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Safety Equipment Corp.?
FDA lists 7 510(k) clearances under the applicant name “American Safety Equipment Corp.” (first 1976, latest 1980), across 6 product codes in 3 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 American Safety Equipment Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Safety Equipment Corp. is 15 days.
Which FDA product codes appear under American Safety Equipment Corp.?
The most frequent FDA product codes under this applicant name are DZH (Saw, Bone, Ac-Powered, 2); DZA (Drill, Dental, Intraoral, 1); DZJ (Driver, Wire, And Bone Drill, Manual, 1).
Next steps
- See all 7 American Safety Equipment Corp. clearances with predicates and recalls
- Run predicate analysis for product code DZH, American Safety Equipment Corp.'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.