Cleared Traditional

K872138 - MR630 ENHANCED DUAL SERVO HEATER HUMIDI...

K872138 is the FDA 510(k) clearance for MR630 ENHANCED DUAL SERVO HEATER HUMIDI... by Fisher & Paykel Allied Products , Ltd.. It is a Class 2 Anesthesiology device (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.

View all Fisher & Paykel Allied Products , Ltd. devices

Submission Details

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.

Device Classification

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 73
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K872138.
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · Fisher &Paykel Healthcare , Ltd. · Mar 1989
STERILE WATER FOR INHALATION USP 2D0799
K851940 · Travenol Laboratories, S.A. · Jun 1985
BIRD HEATED HUMIDIFIER 3201
K842523 · 3M Company · Jul 1984
HUMIDIFIER
K802852 · Airlife, Inc. · Feb 1981