Cleared Traditional

K863377 - MR338 SERVO HEATED DELIVERY HUMIDIFIER

K863377 is an FDA 510(k) clearance for MR338 SERVO HEATED DELIVERY HUMIDIFIER, 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 170-day FDA review.

K863377 · Fisher & Paykel Allied Products , Ltd. · Anesthesiology device
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Feb 1987
Decision
170d
Days
Class 2
Risk

K863377 is an FDA 510(k) clearance for the MR338 SERVO HEATED DELIVERY HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Allied Products , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on February 20, 1987 after a review of 170 days - an extended review 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: 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 - K863377

510(k) Number K863377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date February 20, 1987
Days to Decision 170 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 140d · This submission: 170d
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 K863377.
MEMBRANE HUMIDIFIER
K873472 · Respiratory Support Products, Inc. · Jan 1988
BEAR VH-820 HUMIDIFIER
K873634 · Bear Medical Systems, Inc. · Dec 1987
PREFILLED STERILE WATER FOR INHALATION, USP
K871618 · Automatic Liquid Packaging, Inc. · May 1987
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
K863377 · MR338 SERVO HEATED DELIVERY HUMIDIFIER
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