Summit Industries, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Summit Industries, Inc.” (first 1985, latest 2018), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 79 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 | 1 | 137 |
| 2017 | 0 | — |
| 2018 | 1 | 53 |
| 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 Industries, Inc. took a median 53 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 57 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KPR | System, X-Ray, Stationary | 2 | 2 |
| IXQ | Table, Radiographic, Stationary Top | 1 | 1 |
| IXW | Processor, Radiographic-Film, Automatic | 1 | 1 |
| IXY | Holder, Radiographic Cassette, Wall-Mounted | 1 | 1 |
| IYB | Tube Mount, X-Ray, Diagnostic | 1 | 1 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 1 | 1 |
| IZX | Collimator, Manual, Radiographic | 1 | 1 |
Review panels
- Radiology (8)
Most recent Summit Industries, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K173823 | Amrad Medical AAU Digital Radiography System; Amrad Medical AAU Plus Digital Radiography System; Amrad Medical DFMT Digital Radiography System; Amrad Medical FMT Digital Radiography System | KPR | 2018-02-09 | 53 |
| K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, | KPR | 2016-03-14 | 137 |
| K874908 | C900 X-RAY FILM PROCESSOR | IXW | 1988-02-12 | 73 |
| K874687 | COLLI-MATETM MODEL NO. B800 | IZX | 1987-12-30 | 47 |
| K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR | IXY | 1985-06-05 | 56 |
| K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG | IYB | 1985-05-14 | 116 |
| K850118 | XMA INTEGRATED TABLE | IXQ | 1985-04-09 | 85 |
| K850117 | XMA 325 (X-RAY GENERATOR) | IZO | 1985-04-09 | 85 |
Recalls
4 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-10-28.
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 Medical, Inc. (14 510(k)s)
- Summit World Trade Corp. (10 510(k)s)
- Summit Doppler Systems, Inc. (7 510(k)s)
- Summit Nuclear (6 510(k)s)
- Summit Glove, Inc. (5 510(k)s)
- Summit Technology, Inc. (5 510(k)s)
- Summit Medical Products, Inc. (4 510(k)s)
- Summit Medventures (2 510(k)s)
- Summit Optics, Inc. (2 510(k)s)
- Summit Spine (2 510(k)s)
- Summit Access, LLC (1 510(k)s)
- Summit Durable Medical Equipment, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Summit Industries, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Summit Industries, Inc.” (first 1985, latest 2018), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Summit Industries, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Summit Industries, Inc. is 79 days.
Which FDA product codes appear under Summit Industries, Inc.?
The most frequent FDA product codes under this applicant name are KPR (System, X-Ray, Stationary, 2); IXQ (Table, Radiographic, Stationary Top, 1); IXW (Processor, Radiographic-Film, Automatic, 1).
Next steps
- See all 8 Summit Industries, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KPR, Summit Industries, 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.