Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Surgicare Scientific Laboratory, 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) |
|---|---|---|---|---|---|
| K823670 | E.S. PENCIL | Surgicare Scientific Laboratory, Inc. | 1983-01-12 | 36 | 0 |
| K822447 | SURGICARE MODEL 1000 | Surgicare Scientific Laboratory, Inc. | 1982-10-18 | 63 | 0 |
| K822513 | MODEL #2000 HI-TEMP & #3000 LOW-TEMP | Surgicare Scientific Laboratory, Inc. | 1982-09-21 | 32 | 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