# Bardy Diagnostics, Inc.

- Location (FDA's records): Seattle, WA
- FDA decisions: 7 (2014–2023): 7 510(k) clearances
- Product codes: DSH (7)
- 510(k) review time since 2016: median 30 days, against 76 for FDA's reviews in the same codes and years (3 of 6 faster)
- Predicates its devices cite: 0 (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

## Recent decisions
- K233110: Carnation Ambulatory Monitor (Nov 22, 2023)
- K210036: Carnation Ambulatory Monitor (CAM) (Feb 5, 2021)
- K200870: Carnation Ambulatory Monitor (May 1, 2020)
- K192556: Carnation Ambulatory Monitor (Oct 17, 2019)
- K191471: Carnation Ambulatory Monitor (Aug 30, 2019)
- K191000: Carnation Ambulatory Monitor (May 16, 2019)
- K143067: Carnation Ambulatory Monitor (Dec 22, 2014)

Source page: https://510kreport.com/company/bardy-diagnostics