Cleared Traditional

K881970 - MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER

K881970 is the FDA 510(k) clearance for MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER by Fisher &Paykel Healthcare , Ltd.. It is a Class 2 Anesthesiology device (product code BTT) cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K881970 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Mar 1989
Decision
302d
Days
Class 2
Risk

K881970 is an FDA 510(k) clearance for the MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on March 9, 1989 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Healthcare , Ltd. devices

Submission Details

510(k) Number K881970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1988
Decision Date March 09, 1989
Days to Decision 302 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 140d · This submission: 302d
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 95
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K881970.
DEVILBISS AP-50 COMPRESSOR/NEBULIZER
K900602 · Devilbiss Health Care, Inc. · Apr 1990
BEAR VH820 DISPOSABLE CHAMBER ASSEMBLY
K896315 · Bear Medical Systems, Inc. · Jan 1990
VHS 820 HUMIDIFIER, MODIFICATION
K893034 · Bear Medical Systems, Inc. · Jul 1989
STERILE INHALATION WATER TRANSFER SET
K882582 · Intertech Resources, Inc. · Sep 1988
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
K880979 · Marquest Medical Products, Inc. · Jul 1988
BEAR VH-820 HUMIDIFIER
K873634 · Bear Medical Systems, Inc. · Dec 1987