Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GMP · Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
260 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980638 | ADI SYPHILIS RPR LIQUID CONTROLS | Ampcor Diagnostics, Inc. | 1998-07-06 | 137 | 0 |
| K961998 | QUALITROL SYPHSERO CONTROL SET | Consolidated Technologies, Inc. | 1996-08-08 | 78 | 0 |
| K955143 | RPR LIQUID CONTROLS | Remel, L.P. | 1996-07-30 | 260 | 0 |
| K885298 | VISUWELL REAGIN TEST 960 TEST KIT | Allelix Diagnostics, Inc. | 1989-03-15 | 78 | 0 |
| K875180 | V-TREND RPRL CARD TEST | Texas Immunology, Inc. | 1988-02-04 | 49 | 0 |
| K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | Ncs Diagnostics, Inc. | 1985-08-19 | 126 | 0 |
| K843741 | RPR TEST REDITEST | Biokit USA, Inc. | 1984-10-25 | 30 | 0 |
| K812425 | BECKMAN R.PR CONTROL SERUM SET | Beckman Instruments, Inc. | 1981-09-23 | 30 | 0 |
| K810119 | CONTROL SERUMS FOR NONTREPONEMAL TEST | Hillside Acres, Inc. | 1981-02-09 | 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