Summit Medical, Inc.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Summit Medical, Inc.” (first 2014, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 169 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 |
|---|---|---|
| 2014 | 4 | 156 |
| 2015 | 3 | 111 |
| 2016 | 0 | — |
| 2017 | 1 | 260 |
| 2018 | 1 | 261 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Summit Medical, Inc. took a median 260 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 151 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 8 | 8 |
| DYX | Lock, Wire, And Ligature, Intraoral | 1 | 1 |
Review panels
- General Hospital (8)
- Dental (1)
Most recent Summit Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K180528 | InstruSafe(R) Sterilization Container | KCT | 2018-11-16 | 261 |
| K162046 | MINNE TIES MMF Suture System | DYX | 2017-04-11 | 260 |
| K151166 | Instru-Safe Instrument Protection System | KCT | 2015-08-18 | 109 |
| K150540 | Instru-Safe Instrument Protection System | KCT | 2015-06-22 | 111 |
| K142768 | Instru-Safe Instrument Protection System | KCT | 2015-05-29 | 246 |
| K142630 | Instru-Safe Instrument Protection System | KCT | 2014-12-23 | 97 |
| K141513 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | 2014-12-15 | 189 |
| K140289 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | 2014-06-27 | 142 |
| K133015 | INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM | KCT | 2014-03-13 | 169 |
Recalls
3 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2015-09-03.
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.
- Summit World Trade Corp. (10 510(k)s)
- Summit Doppler Systems, Inc. (7 510(k)s)
- Summit Industries, Inc. (6 510(k)s)
- Summit Nuclear (6 510(k)s)
- Summit Glove, Inc. (5 510(k)s)
- Summit Medical , Ltd. (5 510(k)s)
- Summit Technology, Inc. (5 510(k)s)
- Summit Medical Products, Inc. (4 510(k)s)
- Summit Industries, LLC (2 510(k)s)
- Summit Medventures (2 510(k)s)
- Summit Optics, Inc. (2 510(k)s)
- Summit Spine (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Summit Medical, Inc.?
FDA lists 9 510(k) clearances under the applicant name “Summit Medical, Inc.” (first 2014, latest 2018), across 2 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 Summit Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Summit Medical, Inc. is 169 days.
Which FDA product codes appear under Summit Medical, Inc.?
The most frequent FDA product codes under this applicant name are KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, 8); DYX (Lock, Wire, And Ligature, Intraoral, 1).
Next steps
- See all 9 Summit Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KCT, Summit Medical, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.