Cleared Traditional

K913367 - MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS

K913367 is an FDA 510(k) clearance for MODELS MR410 & MR480 RESPIRATORY HUMIDI..., manufactured by Fisher & Paykel Electronics , Ltd.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K913367 · Fisher & Paykel Electronics , Ltd. · Anesthesiology device
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Jun 1992
Decision
337d
Days
Class 2
Risk

K913367 is an FDA 510(k) clearance for the MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS. 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 June 25, 1992 after a review of 337 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 Electronics , Ltd. devices

FDA 510(k) Submission Details - K913367

510(k) Number K913367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1991
Decision Date June 25, 1992
Days to Decision 337 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 140d · This submission: 337d
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 131
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K913367.
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K934140 · Fisher & Paykel Electronics , Ltd. · Jan 1994
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · Fisher & Paykel Electronics , Ltd. · Jan 1993
OPTI-MOL FILTERED PUNCTURE PIN
K920306 · Automatic Liquid Packaging, Inc. · Apr 1992
MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC
K913368 · Fisher & Paykel Electronics , Ltd. · Jan 1992
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K911770 · Automatic Liquid Packaging, Inc. · Oct 1991