510(k) Report

FDA applicant

CSA Medical, Inc.

Lexington, MA14 decisions2007–20202 recalls

FDA records 14 decisions for CSA Medical, Inc. (Lexington, MA) from 2007 to 2020: 14 510(k) clearances. All are in product code GEH (Unit, Cryosurgical, Accessories). Since 2016 its 510(k)s took a median of 50 days from receipt to decision, against 83 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 11 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided CSA Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2007: 22012: 12014: 12015: 32016: 22017: 42020: 1
2007high 4 (2017) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2015

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — CSA Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like CSA Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEHUnit, Cryosurgical, Accessories14decisions

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 50 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 83 days; 4 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 20 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 11 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K143625truFreeze SystemCSA Medical, Inc. · 20153cite it
  • K171626truFreeze SystemCSA Medical, Inc. · 20172cite it
  • K163244truFreeze SystemCSA Medical, Inc. · 20172cite it
  • K162695truFreeze SystemCSA Medical, Inc. · 20162cite it
  • K070893Cryospray Ablation System, Model CU 8407020500CSA Medical, Inc. · 20072cite it
  • K161557truFreeze SystemCSA Medical, Inc. · 20161cites it

What has FDA decided for it lately?

  • K201183Vortex Radial Spray CatheterCSA Medical, Inc. · 2020
  • K171626truFreeze SystemCSA Medical, Inc. · 2017
  • K172041truFreeze SystemCSA Medical, Inc. · 2017
  • K171522truFreeze Rapid AV Spray KitCSA Medical, Inc. · 2017
  • K163244truFreeze SystemCSA Medical, Inc. · 2017
  • K162695truFreeze SystemCSA Medical, Inc. · 2016
  • K161557truFreeze SystemCSA Medical, Inc. · 2016
  • K152668truFreeze SystemCSA Medical, Inc. · 2015

All 14 as CSA Medical, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K143625CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device Model: CC3-01Mar 25, 2015Class II
  • K133258CSA Medical truFreeze System; Model: CC3-01, a cryogenic surgical device ***The involved…Nov 10, 2014Class II