Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GMD — Predicate Candidate Screening
10 FDA 510(k) clearances under this product code; the 50 most recent screened below.
36 daysmedian FDA review time
387 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | Immuno-Mycologics, Inc. | 2012-03-28 | 218 | 1 |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | Immuno-Mycologics, Inc. | 2011-07-20 | 342 | 0 |
| K930418 | CRYPTO-LEX SYSTEM | Trinity Laboratories, Inc. | 1994-02-17 | 387 | 0 |
| K933997 | PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY | Alexon Biomedical, Inc. | 1993-11-22 | 97 | 0 |
| K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | Meridian Diagnostics, Inc. | 1989-09-08 | 28 | 0 |
| K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | American Scientific Products | 1981-08-31 | 28 | 0 |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | Immuno-Mycologics, Inc. | 1981-03-20 | 24 | 0 |
| K792693 | CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX | Meridian Diagnostics, Inc. | 1980-01-21 | 25 | 0 |
| K791382 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | I M, Inc. | 1978-04-28 | 28 | 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