Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
GON · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K894262 | RUBELLA ANTIGEN AND CONTROL ANTIGEN | Microbix Biosystems, Inc. | 1989-10-16 | 117 | 0 |
| K880157 | MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST | Syva Co. | 1988-02-04 | 22 | 0 |
| K802937 | RUBELLA VIRUS ANTIGENS & CONTROLS | Orion Diagnostica, Inc. | 1980-12-31 | 42 | 0 |
| K802939 | HERPES SIMPLEX TYPE I | Orion Diagnostica, Inc. | 1980-12-31 | 42 | 0 |
| K780996 | RUBELISA TEST KIT | Microbiological Assoc. | 1978-11-22 | 162 | 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