Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DBE · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
18 daysmedian FDA review time
52 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K810983 | ANTISMOOTH MUSCLE ANTIBODY TEST SYS | Immuno-Products Industries | 1981-05-01 | 18 | 0 |
| K800820 | AFT TM SYSTEM ANTISMOOTH MUSCLE ANTIBODY | Calbiochem-Behring Corp. | 1980-04-24 | 13 | 0 |
| K800228 | IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT | Clinical Sciences, Inc. | 1980-02-21 | 16 | 0 |
| K790430 | MEDICA II-F-ASMA TEST KIT | Medica Corp. | 1979-04-23 | 52 | 0 |
| K771155 | ANTI-MITOCHONDRIAL | Meloy Laboratories, Inc. | 1977-08-04 | 37 | 0 |
| K760156 | TEST, (IVDP) SMOOTHMUSCLE ANTIBODY | Zeus Scientific, Inc. | 1976-07-20 | 18 | 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