Cleared Traditional

K813161 - FLO TEM II (BLOOD/FLUID WARMER

K813161 is the FDA 510(k) clearance for FLO TEM II (BLOOD/FLUID WARMER by Datachem, Inc.. It is a Class 2 General Hospital device (product code LGZ) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K813161 · Datachem, Inc. · General Hospital
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Dec 1981
Decision
29d
Days
Class 2
Risk

K813161 is an FDA 510(k) clearance for the FLO TEM II (BLOOD/FLUID WARMER. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by Datachem, Inc. (Walker, US). The FDA issued a Cleared decision on December 9, 1981 after a review of 29 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Datachem, Inc. devices

Submission Details

510(k) Number K813161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1981
Decision Date December 09, 1981
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 K813161.
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