# DPT: Probe, Blood-Flow, Extravascular

- Device class: 2; regulation: 21 CFR 870.2120; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 245 days (middle half 245–245)
- Recalls: 23 (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)
- 2006: 1
- 2007: 3
- 2009: 1
- 2012: 2
- 2013: 3
- 2014: 3
- 2015: 1
- 2016: 1
- 2017: 1
- 2024: 1

## Most-cited predicates
- K032841: Moorldi Infrared Laser Doppler Imager, Model MOORLD12-IR (2003), cited by 6
- K980383: Mooorldi Laser Doppler Imager (1998), cited by 3
- K951832: Laserflo Blood Perfusion Single Use Probes Models Sup-440, Supr-434 Sup-433 (1996), cited by 3
- K052989: DP240 240 Hour Doppler Probe (2006), cited by 2
- K830858: Bio-Probe System-Blood Flow Probe (1983), cited by 2
- K063586: Moorflpi Full-Field Laser Perfusion Imager (2007), cited by 2
- K961368: Trimflo Parenchymal Blood Flow Monitoring Probe Kit (1996), cited by 2
- K120884: Pericam Psi (2012), cited by 2
- K860435: Model 500A Vascular Spectrum Analyzer W/CW Doppler (1986), cited by 1
- K122943: Moorflpi-2 Full-Field Laser Perfusion Imager (2013), cited by 1

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