Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
GMJ — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
50 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | Immuno-Mycologics, Inc. | 1983-05-05 | 50 | 0 |
| K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | American Scientific Products | 1981-12-31 | 31 | 0 |
| K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | Nolan Biological Laboratories, Inc. | 1980-09-26 | 53 | 0 |
| K792701 | HISTOPLASMA CAPSULATUM, ANTIGEN | Meridian Diagnostics, Inc. | 1980-01-23 | 27 | 0 |
| K792708 | HISTOPLASMA CAPSULATUM, MYCELIAL PHASE | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 0 |
| K792704 | HISTOPLASMA CAPSULATUM, ANTIGEN YEAST | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 0 |
| K792711 | HISTOPLASMA CAPSULATUM, ANTISERUM | Meridian Diagnostics, Inc. | 1980-01-17 | 21 | 0 |
| K791394 | HISTOPLASMA MYCELIAL #CF10020X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791384 | FUNGAL IMMUNODIFFUSION KIT #ID1001 | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 0 |
| K791393 | HISTOPLASMA YEAST ANTI #CF10021X | Immuno-Mycologics, Inc. | 1979-08-16 | 36 | 1 |
| K760827 | HISTOPLASMA YEAST ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 0 |
| K760826 | HISTOPLASMA MYCELIAL ANTIGEN | I M, Inc. | 1976-11-01 | 19 | 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