Cleared Traditional

MR290 HUMIDIFICATION CHAMBER SINGLE USE (K934140) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934140 · Fisher & Paykel Electronics , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
152d
Days
Class 2
Risk

K934140 is an FDA 510(k) clearance for the MR290 HUMIDIFICATION CHAMBER SINGLE USE. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher & Paykel Electronics , Ltd. (Auckland, New Zealand, NZ). The FDA issued a Cleared decision on January 24, 1994 after a review of 152 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.

View all Fisher & Paykel Electronics , Ltd. devices

Submission Details

510(k) Number K934140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date January 24, 1994
Days to Decision 152 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 140d · This submission: 152d
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 56
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K934140.
OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997
HUMIDIFIER
K945782 · Respironics, Inc. · Mar 1996
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
STERILE WATER FOR INHALATION USP 2D0799
K851940 · Travenol Laboratories, S.A. · Jun 1985
BIRD HEATED HUMIDIFIER 3201
K842523 · 3M Company · Jul 1984
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · Travenol Laboratories, S.A. · Sep 1980