Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Summit Industries, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
85 daysmedian FDA review time
116 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874908 | C900 X-RAY FILM PROCESSOR | Summit Industries, Inc. | 1988-02-12 | 73 | 0 |
| K874687 | COLLI-MATETM MODEL NO. B800 | Summit Industries, Inc. | 1987-12-30 | 47 | 3 |
| K851440 | RDIOGRAPHIC WALL HOLDER OR FILM RECEPTOR | Summit Industries, Inc. | 1985-06-05 | 56 | 0 |
| K850198 | FLOOR TO WALL OR FLOOR TO CEILING TUBESTAND;RADIOG | Summit Industries, Inc. | 1985-05-14 | 116 | 1 |
| K850118 | XMA INTEGRATED TABLE | Summit Industries, Inc. | 1985-04-09 | 85 | 0 |
| K850117 | XMA 325 (X-RAY GENERATOR) | Summit Industries, Inc. | 1985-04-09 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda