Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NAK · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
192 daysmedian FDA review time
408 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131284 | GSP NEONATAL BIOTINIDASE KIT | Wallac OY | 2013-11-14 | 192 | 0 |
| K090123 | NEONATAL BIOTINIDASE KIT, MODEL 3018 | Perkinelmer, Inc. | 2010-03-05 | 408 | 0 |
| K080294 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT | Astoria-Pacific, Inc. | 2008-11-04 | 274 | 0 |
| K010844 | ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. | Astoria-Pacific, Inc. | 2001-09-21 | 184 | 0 |
| DEN990008 | WALLAC NEONATAL BIOTINIDASE TEST KIT, MODELS NB-1000; NB-400 | Wallac, Inc. | 2000-02-15 | 57 | 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