Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GSB — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
81 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K852933 | MYCOPLASMA SPP SEROLOGICAL REAGENTS | Microbix Biosystems, Inc. | 1985-08-01 | 23 | 0 |
| K843664 | MYCOPLASMA PNEUMONIAE | Institute Virion , Ltd. | 1984-10-25 | 38 | 0 |
| K834338 | MYCOPLASMA PNEUMONIAE CF ANTIGEN | Hillcrest Biologicals | 1984-02-27 | 77 | 0 |
| K832132 | SERA-TEK MYCOPLASMA ANTIBODY TEST | Miles Laboratories, Inc. | 1983-09-20 | 81 | 0 |
| K802934 | MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL | Orion Diagnostica, Inc. | 1980-12-31 | 42 | 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