Suncoast Medical Manufacturers, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Suncoast Medical Manufacturers, Inc.” (first 1984, latest 1984), across 7 product codes in 4 review panels. Median 510(k) review time under this name: 93 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 12 | 12 |
| HQP | Unit, Cautery, Thermal, Battery-Powered | 4 | 4 |
| FTF | Illuminator, Non-Remote | 3 | 3 |
| KYT | Light, Examination, Medical, Battery Powered | 2 | 2 |
| GET | Motor, Surgical Instrument, Pneumatic Powered | 1 | 1 |
| HTP | File | 1 | 1 |
Plus 1 more product codes.
Review panels
- General and Plastic Surgery (16)
- Ophthalmic (4)
- General Hospital (2)
- Orthopedic (1)
Most recent Suncoast Medical Manufacturers, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841604 | ADJUST-A-TEMP HIGH TEMPERATURE | GEI | 1984-12-07 | 232 |
| K841603 | ADJUST-A-TEMP MICRO | GEI | 1984-12-07 | 232 |
| K841509 | REPLACE-A-TIP ADJUSTABLE HIGH TEMP. | GEI | 1984-12-07 | 240 |
| K841459 | REPLACE-A-TIP ADJUST. LOW TEMP.- | GEI | 1984-12-07 | 242 |
| K841591 | PYRO-TIP | GEI | 1984-10-31 | 196 |
| K840376 | SURG-A STAT LOOP TIP | GEI | 1984-10-26 | 273 |
| K840387 | SURG-A-STAT LOOP TIP 2 | GEI | 1984-07-23 | 175 |
| K840377 | SURG-A-STAT CARDIOVASCULAR TIP | GEI | 1984-07-23 | 178 |
| K840375 | SURG-A-STAT LOOP TIP 15 | GEI | 1984-07-23 | 178 |
| K840370 | SURG-A-STAT VASECTOMY TIP | GET | 1984-07-23 | 178 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Suncoast Medical Manufacturers, 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.
- Suncoast Dental Corp. (2 510(k)s)
- Suncoast Dental, Inc. Dba Tatum Surgical (1 510(k)s)
- Suncoast Medical Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Suncoast Medical Manufacturers, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Suncoast Medical Manufacturers, Inc.” (first 1984, latest 1984), across 7 product codes in 4 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 Suncoast Medical Manufacturers, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Suncoast Medical Manufacturers, Inc. is 93 days.
Which FDA product codes appear under Suncoast Medical Manufacturers, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 12); HQP (Unit, Cautery, Thermal, Battery-Powered, 4); FTF (Illuminator, Non-Remote, 3).
Next steps
- See all 31 Suncoast Medical Manufacturers, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Suncoast Medical Manufacturers, 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.