Cleared Traditional

K240457 - C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240457 · Pentax of America, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
159d
Days
Class 2
Risk

K240457 is an FDA 510(k) clearance for the C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System). Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Pentax of America, Inc. (Montvale, US). The FDA issued a Cleared decision on July 24, 2024 after a review of 159 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4350 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Pentax of America, Inc. devices

Submission Details

510(k) Number K240457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2024
Decision Date July 24, 2024
Days to Decision 159 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 114d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEH Unit, Cryosurgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEH Unit, Cryosurgical, Accessories

All 260
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K240457.
ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit
K253230 · Erbe Elektromedizin GmbH · Apr 2026
Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover)
K252198 · Medical Brands Laboratories B.V. · Apr 2026
XSense Cryoablation System with CryoProbes
K260377 · IceCure Medical , Ltd. · Feb 2026
CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01)
K251928 · Medinice S.A. · Feb 2026
Dr. Yglo Skin Tag Remover
K251524 · Theotclab Healthcare B.V. · Jan 2026
Focused Cryotherapy System
K250742 · Focused Cryo, Inc. · Dec 2025