Cleared Traditional

K841295 - HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS

K841295 is an FDA 510(k) clearance for HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS, manufactured by Bow/Parm. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K841295 · Bow/Parm · Anesthesiology device
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Aug 1984
Decision
132d
Days
Class 2
Risk

K841295 is an FDA 510(k) clearance for the HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Bow/Parm (Mchenry, US). The FDA issued a Cleared decision on August 8, 1984 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K841295

510(k) Number K841295 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1984
Decision Date August 08, 1984
Days to Decision 132 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 140d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 184
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K841295.
RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
K853146 · Automatic Liquid Packaging, Inc. · Aug 1985
STERILE WATER FOR INHALATION USP 2D0799
K851940 · Travenol Laboratories, S.A. · Jun 1985
VAPOR-PHASE HUMIDIFIER SYS-ADVANCED
K843932 · Inspiron Corp. · Oct 1984
VH820 HUMIDIFIER
K842340 · Bear Medical Systems, Inc. · Jul 1984
BIRD HEATED HUMIDIFIER 3201
K842523 · 3M Company · Jul 1984
NEBULO 28 NEBULIZER KIT
K841158 · Inspiron Corp. · Mar 1984
K841295 · HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS
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