Cleared Traditional

K883873 - INFUSION FLUID WARMER

K883873 is the FDA 510(k) clearance for INFUSION FLUID WARMER by Pmt Corp.. It is a Class 2 General Hospital device (product code LGZ) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K883873 · Pmt Corp. · General Hospital
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Feb 1989
Decision
168d
Days
Class 2
Risk

K883873 is an FDA 510(k) clearance for the INFUSION FLUID WARMER. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Pmt Corp. (Chanhassen, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 168 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 Pmt Corp. devices

Submission Details

510(k) Number K883873 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date February 28, 1989
Days to Decision 168 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 129d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 19
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K883873.
AMSCO WARMING CABINET
K092823 · STERIS Corporation · Dec 2009
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
K072080 · Smiths Medical Asd, Inc. · Jun 2008
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc. · Oct 2001
BT 794-BLOOD/FLUID WARMER
K822098 · Electromedics, Inc. · Aug 1982