Cleared Traditional

K911383 - HOTLINE FLUID WARMER

K911383 is an FDA 510(k) clearance for HOTLINE FLUID WARMER, manufactured by Level 1 Technologies, Inc.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K911383 · Level 1 Technologies, Inc. · General Hospital
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Oct 1991
Decision
203d
Days
Class 2
Risk

K911383 is an FDA 510(k) clearance for the HOTLINE FLUID WARMER. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Level 1 Technologies, Inc. (Potomac, US). The FDA issued a Cleared decision on October 17, 1991 after a review of 203 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 - K911383

510(k) Number K911383 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1991
Decision Date October 17, 1991
Days to Decision 203 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 129d · This submission: 203d
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 K911383.
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
HOT SACK
K921395 · C.F. Electronics, Inc. · Sep 1992
HEATWAVE
K904252 · Medadvances, Inc. · Oct 1990
BIOTEMP
K896018 · Medadvances, Inc. · Feb 1990
INFUSION FLUID WARMER
K883873 · Pmt Corp. · Feb 1989
K911383 · HOTLINE FLUID WARMER
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