510(k) Report

FDA applicant

C2 Therapeutics, Inc.

Redwood, Ca, CA10 decisions2010–20186 recalls

FDA records 10 decisions for C2 Therapeutics, Inc. (Redwood, Ca, CA) from 2010 to 2018: 10 510(k) clearances. Most are in product codes GEH (Unit, Cryosurgical, Accessories) and OCX (Endoscopic Irrigation/Suction System). Since 2016 its 510(k)s took a median of 239 days from receipt to decision, against 60 for FDA’s reviews in the same codes and years. Its devices cite 17 predicates, 9 of them its own earlier devices. 6 recalls are linked to its devices.

FDA’s records also spell it “C2 Therapeutics”.

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 C2 Therapeutics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2010: 12013: 12015: 32016: 32017: 12018: 1
2010high 3 (2015) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

5in 2018

2017: 12018: 5
2010high 5 (2018) · low 0 (2010)2026

Class I Class II/III not classified

FIG. 1 — C2 Therapeutics, Inc. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like C2 Therapeutics, 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, Accessories8decisions
  • OCXEndoscopic Irrigation/Suction System1decision
  • FEDEndoscopic Access Overtube, Gastroenterology-Urology1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 239 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 60 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 17 predicates; 9 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 11 times; 9 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.

  • K131523Cryoballoon Focal Ablation SystemC2 Therapeutics · 20133cite it
  • K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 20152cite it
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 20162cite it
  • K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 20171cites it
  • K152140Boa Endoscopic ValveC2 Therapeutics, Inc. · 20151cites it
  • K101825Cryoballoon Ablation SystemC2 Therapeutics · 20101cites it

What has FDA decided for it lately?

  • K163684C2 CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 20184 recalls
  • K161202C2 Cryoballoon Ablation SystemC2 Therapeutics, Inc. · 20171 recall
  • K160994C2 CryoBalloon Focal Pear CatheterC2 Therapeutics, Inc. · 2016
  • K152329Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation SystemC2 Therapeutics, Inc. · 20161 recall
  • K153541Coldplay CryoBalloon® Ablation SystemC2 Therapeutics, Inc. · 2016
  • K152140Boa Endoscopic ValveC2 Therapeutics, Inc. · 2015
  • K151054Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation SystemC2 Therapeutics, Inc. · 2015
  • K150083Sidecar External Working ChannelC2 Therapeutics · 2015

All 7 as C2 Therapeutics, Inc. →All 3 as C2 Therapeutics →

What has been recalled?

6 recalls linked to its devices; the latest:

  • K163684C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2…Dec 3, 2018Class II
  • K163684Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product…Dec 3, 2018Class II
  • K163684Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX.…Dec 3, 2018Class II
  • K163684Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX.…Dec 3, 2018Class II
  • K131523C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a…Mar 30, 2018Class II
  • K161202C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; Cryosurgical…Jan 6, 2017Class II