Cleared Traditional

K921395 - HOT SACK

K921395 is an FDA 510(k) clearance for HOT SACK, manufactured by C.F. Electronics, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K921395 · C.F. Electronics, Inc. · General Hospital
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Sep 1992
Decision
162d
Days
Class 2
Risk

K921395 is an FDA 510(k) clearance for the HOT SACK. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by C.F. Electronics, Inc. (Commack, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 162 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all C.F. Electronics, Inc. devices

FDA 510(k) Submission Details - K921395

510(k) Number K921395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date September 02, 1992
Days to Decision 162 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 129d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LGZ Device Classification - Class 2, Special Controls

Product Code LGZ Warmer, Thermal, Infusion Fluid
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 Hospital devices follow this clearance model.

Regulatory Peers - LGZ Warmer, Thermal, Infusion Fluid

All 46
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K921395.
HEAT STACK
K980086 · Medical Solutions, Inc. · Mar 1998
BIEGLER BW385L BLOOD & INFUSION WARMER
K954769 · Biegler Medical Products, Inc. · Aug 1996
DRUGBOX
K955659 · C.F. Electronics, Inc. · May 1996
INFUSION FLUID WARMER
K883873 · Pmt Corp. · Feb 1989
BT 794-BLOOD/FLUID WARMER
K822098 · Electromedics, Inc. · Aug 1982