# NWM: Immunoassay, Anti-Seizure Drug

- Device class: 2; regulation: 21 CFR 862.3350; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 469 days (middle half 469–469)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 1
- 2007: 1
- 2009: 2
- 2021: 1

## Most-cited predicates
- K083799: Topiramate Assay, Ark Topiramate Calibrator and Ark Topiramate Control, Models 5015-0001-000, 5015-0002-00, 5015-0003-00 (2009), cited by 4
- K051211: QMS Zonisamide Reagents, Calibrators and Controls (2005), cited by 2
- K070645: Seradyn QMS Topiramate (2007), cited by 1

Source page: https://510kreport.com/product-code/NWM
Data by year (CSV): https://510kreport.com/product-code/NWM.csv