# CSA Medical, Inc.

- Location (FDA's records): Lexington, MA
- FDA decisions: 14 (2007–2020): 14 510(k) clearances
- Product codes: GEH (14)
- 510(k) review time since 2016: median 50 days, against 83 for FDA's reviews in the same codes and years (4 of 7 faster)
- Predicates its devices cite: 20 (11 its own); citations of its devices by later devices: 15 (11 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Crymed Technologies, Inc.: 5 (https://510kreport.com/company/crymed-technologies)
- Csa Medial, Inc.: 1 (https://510kreport.com/company/csa-medial)
- Aframe Digital, Inc.: 1 (https://510kreport.com/company/aframe-digital)
- Clearcount Medical Solutions, Inc.: 1 (https://510kreport.com/company/clearcount-medical-solutions)
- IceCure Medical, Ltd.: 1 (https://510kreport.com/company/icecure-medical)

## Firms that cite its devices most
- C2 Therapeutics, Inc.: 2 (https://510kreport.com/company/c2-therapeutics)
- STERIS Corporation: 1 (https://510kreport.com/company/steris)
- Csa Medial, Inc.: 1 (https://510kreport.com/company/csa-medial)

## Its most-cited devices
- K143625: truFreeze System (2015), cited by 3
- K171626: truFreeze System (2017), cited by 2
- K163244: truFreeze System (2017), cited by 2
- K162695: truFreeze System (2016), cited by 2
- K070893: Cryospray Ablation System, Model CU 8407020500 (2007), cited by 2
- K161557: truFreeze System (2016), cited by 1

## Recent decisions
- K201183: Vortex Radial Spray Catheter (Dec 7, 2020)
- K171626: truFreeze System (Aug 30, 2017)
- K172041: truFreeze System (Jul 27, 2017)
- K171522: truFreeze Rapid AV Spray Kit (Jul 14, 2017)
- K163244: truFreeze System (May 24, 2017)
- K162695: truFreeze System (Oct 25, 2016)
- K161557: truFreeze System (Jul 26, 2016)
- K152668: truFreeze System (Oct 14, 2015)

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