Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Instrument Research Assoc., 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) |
|---|---|---|---|---|---|
| K791510 | BLUE FIELD ENTOPTOSCOPE BFE100 | Medical Instrument Research Assoc., Inc. | 1979-12-11 | 131 | 0 |
| K780987 | SOFT SILICONE ELASTOMER SPONGE EXPLANT | Medical Instrument Research Assoc., Inc. | 1978-09-28 | 106 | 0 |
| K770888 | POMERANTZEFF EQUATOR PLUS CAMERA | Medical Instrument Research Assoc., Inc. | 1977-06-03 | 18 | 0 |
| K760550 | IMPLANT, SILICONE AND TANTALUM | Medical Instrument Research Assoc., Inc. | 1976-10-05 | 36 | 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