Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microprobe Corp. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
176 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931151 | AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA | Microprobe Corp. | 1993-06-18 | 102 | 0 |
| K931374 | AFFIRM VPIII MICROBIAL IDENTIFICATION TEST | Microprobe Corp. | 1993-06-15 | 89 | 1 |
| K922457 | AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA | Microprobe Corp. | 1992-09-25 | 122 | 0 |
| K923133 | AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS | Microprobe Corp. | 1992-09-25 | 88 | 0 |
| K920536 | AFFIRM VP SAMPLE COLLECTION SET | Microprobe Corp. | 1992-07-30 | 176 | 0 |
| K923268 | AFFIRM PROCESSOR | Microprobe Corp. | 1992-07-30 | 24 | 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