Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GSA · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
115 daysmedian FDA review time
281 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950073 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYST | Shared Systems, Inc. | 1995-10-17 | 281 | 0 |
| K910833 | COLOR VUE TM- MYCOPLASMA PNEUMONIAE | Seradyn, Inc. | 1991-06-24 | 117 | 0 |
| K905493 | MERISTAR-MP | Meridian Diagnostics, Inc. | 1991-01-30 | 54 | 0 |
| K903958 | SEROFAST | Intl. Mycoplasma/Mdc Assoc. | 1990-12-21 | 115 | 0 |
| K883083 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1988-10-25 | 96 | 0 |
| K862630 | MYCOPLASMA PNEUMONIAE ANTIBODY LATEX TEST SYSTEM | Medical Diagnostic Technologies, Inc. | 1986-09-03 | 55 | 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