Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Engineered Medical Solutions Co., LLC · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133425 | SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL S | Engineered Medical Solutions Co., LLC | 2013-12-05 | 27 | 0 |
| K071180 | SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001 | Engineered Medical Solutions Co., LLC | 2007-06-20 | 51 | 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