Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CDF — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
48 daysmedian FDA review time
120 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K953077 | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM | Beckman Instruments, Inc. | 1996-01-05 | 189 | 0 |
| K934977 | MODEL 5500 CEAS | Esa, Inc. | 1994-01-11 | 84 | 0 |
| K895288 | HVA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | 1989-10-31 | 67 | 0 |
| K895287 | VMA EIA KIT YAMASA | Yamasa Shoy Co., Ltd. | 1989-10-30 | 66 | 0 |
| K873372 | HVA & HOMOVANILLIC ACID BY HPLC METHOD | Bio-Rad | 1987-12-22 | 120 | 0 |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | Sterling Diagnostics, Inc. | 1986-07-07 | 48 | 0 |
| K861010 | VMA BY HPLC TEST (VANILMANDELIC ACID) | Bio-Rad | 1986-05-01 | 44 | 0 |
| K853041 | TRIGLYCERIDES LCK 124 | German American Chamber of Commerce, Inc. | 1985-08-12 | 24 | 0 |
| K843379 | VMA ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-09-28 | 31 | 0 |
| K810992 | HELENA VMA-SMC COLUMN METHOD | Helena Laboratories | 1981-04-29 | 16 | 0 |
| K791837 | VMA BY COLUMN TEST | Bio-Rad | 1979-10-30 | 46 | 0 |
| K772151 | URINARY VMA - SCREEN TEST KIT | Eppendorf-Brinkmann, Inc. | 1977-11-30 | 15 | 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