Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pro-Tronics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
183 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950971 | MOBIL C-ARM, REGURBISHED, VARIOUS MODELS | Pro-Tronics, Inc. | 1995-04-11 | 49 | 0 |
| K944442 | GENERAL ELECTRIC AMX 110, AMX II AND AMX 3 | Pro-Tronics, Inc. | 1995-03-14 | 183 | 0 |
| K902610 | GENERAL ELECTRIC AMX 3 | Pro-Tronics, Inc. | 1990-07-02 | 20 | 0 |
| K891143 | GENERAL ELECTRIC AMX 110 | Pro-Tronics, Inc. | 1989-05-03 | 61 | 0 |
| K891142 | GENERAL ELECTRIC AMX II | Pro-Tronics, Inc. | 1989-05-01 | 59 | 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