# Stat Medical Devices

- Location (FDA's records): North Miami Beach, FL
- FDA decisions: 4 (2009–2023): 4 510(k) clearances
- Names in FDA's records: Stat Medical Devices (3); Stat Medical Devices, Inc. (1)
- Product codes: QRK (3), FMI (1)
- 510(k) review time since 2016: median 203 days, against 89 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 4 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Roche Diabetes Care, Inc.: 3 (https://510kreport.com/company/roche-diabetes-care)
- Emergogroup, Inc.: 1 (https://510kreport.com/company/emergogroup)

## Recent decisions
- K230310: STAT Medical Device Lancing System (Sep 8, 2023)
- K222617: EasyTouch Lancing Device (Mar 21, 2023)
- K223815: ONE DROP Lancing Device (Feb 15, 2023)
- K092016: Super-Fine Pen Needle (Oct 2, 2009)

Source page: https://510kreport.com/company/stat-medical-devices