Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Source Production & Equipment Co., Inc. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132969 | SPEC MODEL M15 | Source Production & Equipment Co., Inc. | 2014-01-02 | 101 | 0 |
| K090366 | SPEC MODEL M-31 | Source Production & Equipment Co., Inc. | 2009-04-22 | 68 | 0 |
| K052947 | SOURCE PRODUCTION & EQUIPMENT CO, INC., MODEL M-19 IR-192 BR | Source Production & Equipment Co., Inc. | 2006-04-19 | 181 | 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