Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NWM — Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
168 daysmedian FDA review time
469 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201089 | ARK Lacosamide Assay | Ark Diagnostics, Inc. | 2021-08-05 | 469 | 0 |
| K091884 | ARK ZONISAMIDE ASSAY, ARK ZONISAMIDE CALIBRATOR, AND ARK ZON | Ark Diagnostics, Inc. | 2009-12-09 | 168 | 0 |
| K083799 | TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMA | Ark Diagnostics, Inc. | 2009-04-16 | 115 | 0 |
| K070645 | SERADYN QMS TOPIRAMATE | Seradyn, Inc. | 2007-05-17 | 70 | 0 |
| K051211 | QMS ZONISAMIDE REAGENTS, CALIBRATORS AND CONTROLS | Seradyn, Inc. | 2005-11-18 | 191 | 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