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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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 75
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K921395.
THERM O DRUG MODEL HT-747
K922786 · C.F. Electronics, Inc. · Jan 1993
QWIK-1(TM) IN-LINE IV FLUID WARMER
K914867 · Microwave Medical Systems, Inc. · Oct 1992
ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.
K914364 · North American Technical Services Corp. · Sep 1992
HOTLINE FLUID WARMER
K911383 · Level 1 Technologies, Inc. · Oct 1991
HEATWAVE
K904252 · Medadvances, Inc. · Oct 1990
BIOTEMP
K896018 · Medadvances, Inc. · Feb 1990
K921395 · HOT SACK
Download PDF FDA Summary C.F. Electronics, Inc.