Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Labarge, 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) |
|---|---|---|---|---|---|
| K792037 | NON-A-THERM | Labarge, Inc. | 1979-11-13 | 33 | 0 |
| K771520 | ESOPHAGEAL STETHOSCOPE | Labarge, Inc. | 1977-09-23 | 46 | 0 |
| K771411 | ESOPHAGEAL STETH. TEMP. SENSOR | Labarge, Inc. | 1977-09-23 | 53 | 0 |
| K760720 | MON-A-THERM TEMPARATURE MONITOR SYS | Labarge, Inc. | 1976-11-30 | 64 | 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