Cleared Traditional

K940140 - HM-CRYO

K940140 is an FDA 510(k) clearance for HM-CRYO, manufactured by Hill-Med, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEH cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K940140 · Hill-Med, Inc. · General & Plastic Surgery device
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Jun 1994
Decision
167d
Days
Class 2
Risk

K940140 is an FDA 510(k) clearance for the HM-CRYO. Classified as Unit, Cryosurgical, Accessories (product code GEH), Class II - Special Controls.

Submitted by Hill-Med, Inc. (Miami, US). The FDA issued a Cleared decision on June 27, 1994 after a review of 167 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 Hill-Med, Inc. devices

FDA 510(k) Submission Details - K940140

510(k) Number K940140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1994
Decision Date June 27, 1994
Days to Decision 167 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 115d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEH Device Classification - Class 2, Special Controls

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 152
Devices cleared under the same product code (GEH) and FDA review panel - the closest regulatory comparables to K940140.
MEDI-FRIG
K954703 · Ellman Intl., Inc. · Feb 1996
CANDELA CRYO-PROBE HOLDER
K954872 · Candela Laser Corp. · Feb 1996
CANDELA CRYOSYSTEM CS-5
K953294 · Candela Laser Corp. · Oct 1995
ERBOKRYO CA CRYOSURGICAL SYSTEM
K934261 · Erbe Elektromedizin GmbH · Apr 1994
WALLACH ULTRA FREEZE
K935010 · Wallach Surgical Devices, Inc. · Feb 1994
HISTOFREEZER
K931299 · Solarcare Technologies Corp,Inc. · Aug 1993