Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DAO · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
98 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040431 | ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 | Roche Diagnostics Corp. | 2004-03-10 | 20 | 1 |
| K982639 | SPIFE URINE IFE | Helena Laboratories | 1998-11-04 | 98 | 0 |
| K955908 | BOEHRINGER MANNHEIM IGM ASSAY | Boehringer Mannheim Corp. | 1996-02-09 | 42 | 0 |
| K850586 | SPQ TEST SYSTEM FOR IMMUNOGLOBULIN M | Applications Lab | 1985-03-14 | 29 | 0 |
| K841992 | MODIFICATION TO ACS CORONARY GUIDING | Advanced Cardiovascular Systems, Inc. | 1984-06-11 | 47 | 0 |
| K812487 | IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM | Dako Corp. | 1981-09-23 | 23 | 0 |
| K800450 | GEMENI IGM ASSAY | Electro-Nucleonics Laboratories, Inc. | 1980-04-24 | 55 | 0 |
| K790705 | ANTISERUM TO HUMAN IGM | Kent Laboratories, Inc. | 1979-04-12 | 0 | 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