Cleared Traditional

CryoLab (K190407) - FDA 510(k) Clearance

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

K190407 · Cryoconcepts LP · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
60d
Days
Class 2
Risk

K190407 is an FDA 510(k) clearance for the CryoLab. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Cryoconcepts LP (Bethlehem, US). The FDA issued a Cleared decision on April 22, 2019 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cryoconcepts LP devices

Submission Details

510(k) Number K190407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2019
Decision Date April 22, 2019
Days to Decision 60 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
55d faster than avg
Panel avg: 115d · This submission: 60d
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 64
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K190407.
IceSense 3, ProSense, MultiSense
K183213 · IceCure Medical , Ltd. · Dec 2019
Claritag
K190747 · Dgi Technologies · Oct 2019
C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge
K190194 · Pentax Medical, A Division of Pentax of America, Inc. · May 2019
CryoTouch
K183601 · Cryoconcepts LP · Apr 2019
ClariFix
K190356 · Arrinex, Inc. · Feb 2019
Frozen C
K182392 · B.M. Tech. Worldwide Co., Ltd. · Oct 2018