# DPW: Flowmeter, Blood, Cardiovascular

- Device class: 2; regulation: 21 CFR 870.2100; FDA's rule: 510(k) required
- FDA decisions: 138
- 510(k) review time 2021–2025: median 127 days (middle half 103–149)
- Recalls: 11 (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)
- 2016: 1
- 2018: 2
- 2019: 3
- 2020: 2
- 2021: 2
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 3
- 2026: 2

## Most-cited predicates
- K972798: Dynemo 3000 (1998), cited by 4
- K872048: Transonic Flowmeter (1988), cited by 4
- K031706: Cardioq, Model 9051-7005 (2003), cited by 3
- K896515: Laserflo Blood Perfusion Monitor, Model BPM2 (1990), cited by 3
- K013803: Flowguard Device (2002), cited by 3
- K111542: Deltex Medical Cardioq Edm (2011), cited by 3
- K082870: Vti Intraoperative Doppler Systems (2008), cited by 2
- K050601: Smartdop 45 Vascular Doppler (2005), cited by 2
- K915550: Mini Doppler II Ultrasound Blood Flow Detector (1992), cited by 2
- K011899: PF 5050 Pressure Unit, Model PF 5050 (2001), cited by 2

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