Cleared Traditional

K872138 - MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER

K872138 is an FDA 510(k) clearance for MR630 ENHANCED DUAL SERVO HEATER 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 126-day FDA review.

K872138 · Fisher & Paykel Allied Products , Ltd. · Anesthesiology device
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Oct 1987
Decision
126d
Days
Class 2
Risk

K872138 is an FDA 510(k) clearance for the MR630 ENHANCED DUAL SERVO HEATER 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 October 7, 1987 after a review of 126 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 - K872138

510(k) Number K872138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1987
Decision Date October 07, 1987
Days to Decision 126 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 140d · This submission: 126d
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 K872138.
INTERTECH STERILE WATER FOR INHALATION
K881184 · Delmed, Inc. · May 1988
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
K872138 · MR630 ENHANCED DUAL SERVO HEATER HUMIDIFIER
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