Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Source Production and Equipment Co., Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162573 | Source Production & Equipment Co., Inc. Model M14 192Iridium | Source Production and Equipment Co., Inc. | 2016-11-04 | 50 | 0 |
| K161396 | SPEC Model M23 | Source Production and Equipment Co., Inc. | 2016-08-17 | 90 | 0 |
| K161395 | SPEC Model M13 | Source Production and Equipment Co., Inc. | 2016-07-06 | 48 | 0 |
| K150895 | SPEC Model M16 | Source Production and Equipment Co., Inc. | 2015-06-19 | 78 | 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