Cleared Traditional

K843903 - HEATED RESPIRATORY HUMIDIFIER MR428

K843903 is an FDA 510(k) clearance for HEATED RESPIRATORY HUMIDIFIER MR428, manufactured by Fisher & Paykel Allied Products , Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K843903 · Fisher & Paykel Allied Products , Ltd. · Anesthesiology device
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Oct 1984
Decision
19d
Days
Class 2
Risk

K843903 is an FDA 510(k) clearance for the HEATED RESPIRATORY HUMIDIFIER MR428. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Allied Products , Ltd. (Panmure, New Zealand, NZ). The FDA issued a Cleared decision on October 22, 1984 after a review of 19 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K843903

510(k) Number K843903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1984
Decision Date October 22, 1984
Days to Decision 19 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 140d · This submission: 19d
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 K843903.
COLBY LEVEL ALARM
K863955 · Respiratory Care, Inc. · Nov 1986
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
K843903 · HEATED RESPIRATORY HUMIDIFIER MR428
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