Fraser Sweatman, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Fraser Sweatman, Inc.” (first 1976, latest 1977), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 17 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 |
|---|---|---|---|
| BSF | Absorber, Carbon-Dioxide | 1 | 1 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
| CBN | Apparatus, Gas-Scavenging | 1 | 1 |
| FPP | Stretcher, Hand-Carried | 1 | 1 |
| HSS | Halter, Head, Traction | 1 | 1 |
Review panels
- Anesthesiology (4)
- General Hospital (1)
- Physical Medicine (1)
Most recent Fraser Sweatman, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K771299 | EMERGENCY OXYGEN RESUSCITATOR | BTL | 1977-08-04 | 21 |
| K770911 | MEDISHIELD JORDON LIFTING FRAME | FPP | 1977-06-27 | 39 |
| K770910 | MEDISHIELD CERVICAL COLLAR | HSS | 1977-05-25 | 6 |
| K761140 | FRASER SWEATMAN'S DOUBLE MASK | CBN | 1976-12-09 | 13 |
| K760766 | PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER | BZR | 1976-10-08 | 4 |
| K760076 | ABSORBER, ANESTHESIA CIRCLE SYS, CO2 | BSF | 1976-07-16 | 28 |
Recalls
openFDA lists no recalls under a recalling firm named Fraser Sweatman, 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.
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.
- Fraser Harlake, Inc. (9 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Fraser Sweatman, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Fraser Sweatman, Inc.” (first 1976, latest 1977), 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 Fraser Sweatman, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Fraser Sweatman, Inc. is 17 days.
Which FDA product codes appear under Fraser Sweatman, Inc.?
The most frequent FDA product codes under this applicant name are BSF (Absorber, Carbon-Dioxide, 1); BTL (Ventilator, Emergency, Powered (Resuscitator), 1); BZR (Mixer, Breathing Gases, Anesthesia Inhalation, 1).
Next steps
- See all 6 Fraser Sweatman, Inc. clearances with predicates and recalls
- Run predicate analysis for product code BSF, Fraser Sweatman, 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.