Cleared Traditional

K914364 - ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.

K914364 is an FDA 510(k) clearance for ASTOTHERM IFT 250, manufactured by North American Technical Services Corp.. The device is a Class 2 General Hospital device with product code LGZ cleared through the Traditional 510(k) pathway after a 345-day FDA review.

K914364 · North American Technical Services Corp. · General Hospital
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Sep 1992
Decision
345d
Days
Class 2
Risk

K914364 is an FDA 510(k) clearance for the ASTOTHERM IFT 250, IFT 260, ASTOTUBE VARIOUS NO.. Classified as Warmer, Thermal, Infusion Fluid (product code LGZ), Class II - Special Controls.

Submitted by North American Technical Services Corp. (Port Jefferson, US). The FDA issued a Cleared decision on September 10, 1992 after a review of 345 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 North American Technical Services Corp. devices

FDA 510(k) Submission Details - K914364

510(k) Number K914364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1991
Decision Date September 10, 1992
Days to Decision 345 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
216d slower than avg
Panel avg: 129d · This submission: 345d
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 27
Devices cleared under the same product code (LGZ) and FDA review panel - the closest regulatory comparables to K914364.
BELMONT FLUID MANAGEMENT SYSTEM, MODEL FMS2000
K032674 · Belmont Instrument Corp. · Sep 2003
COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200
K012832 · Nxstage Medical, Inc. · Oct 2001
TEMPO AND TEMP H20
K973748 · Smith · Mar 1998
INFUSION FLUID WARMER
K883873 · Pmt Corp. · Feb 1989
BT 794-BLOOD/FLUID WARMER
K822098 · Electromedics, Inc. · Aug 1982