# Osprey Medical, Inc.

- Location (FDA's records): Minnetonka, MN
- FDA decisions: 15 (2013–2019): 15 510(k) clearances
- Names in FDA's records: Osprey Medical, Inc. (14); Osprey Medical (1)
- Product codes: DXT (15)
- 510(k) review time since 2016: median 80 days, against 172 for FDA's reviews in the same codes and years (6 of 8 faster)
- Predicates its devices cite: 29 (23 its own); citations of its devices by later devices: 23 (23 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
- Acist Medical Systems, Inc.: 4 (https://510kreport.com/company/acist-medical-systems)
- Medline Industries, Inc.: 2 (https://510kreport.com/company/medline-industries)

## Its most-cited devices
- K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (2017), cited by 5
- K140425: Contrast Modulation System (2014), cited by 4
- K161505: DyeVert NG Contrast Modulation System (2016), cited by 3
- K181936: DyeVert PLUS EZ Contrast Reduction System (2018), cited by 2
- K150485: AVERT Contrast Modulation System (2015), cited by 2
- K171217: DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (2017), cited by 1

## Recent decisions
- K190102: DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System (Oct 17, 2019)
- K183267: DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System (Dec 20, 2018)
- K181936: DyeVert PLUS EZ Contrast Reduction System (Oct 25, 2018)
- K171698: Smart Syringe (Jul 7, 2017)
- K171217: DyeVert Plus Contrast Reduction System, DyeVert NG Contrast Reduction System (May 26, 2017)
- K163054: DyeVert Plus Contrast Modulation/Monitoring System, Contrast Monitoring System (Mar 8, 2017)
- K161505: DyeVert NG Contrast Modulation System (Aug 3, 2016)
- K153141: DyeVert Contrast Modulation System (Feb 4, 2016)

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