Cleared Traditional

K913368 - MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC

K913368 is an FDA 510(k) clearance for MODELS MR700/MR720/MR730 DUAL SERVO RES..., 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 173-day FDA review.

K913368 · Fisher & Paykel Electronics , Ltd. · Anesthesiology device
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Jan 1992
Decision
173d
Days
Class 2
Risk

K913368 is an FDA 510(k) clearance for the MODELS MR700/MR720/MR730 DUAL SERVO RESP HUMID ACC. 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 13, 1992 after a review of 173 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

FDA 510(k) Submission Details - K913368

510(k) Number K913368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1991
Decision Date January 13, 1992
Days to Decision 173 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
33d slower than avg
Panel avg: 140d · This submission: 173d
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 K913368.
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · Fisher & Paykel Electronics , Ltd. · Jan 1993
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS
K913367 · Fisher & Paykel Electronics , Ltd. · Jun 1992
OPTI-MOL FILTERED PUNCTURE PIN
K920306 · Automatic Liquid Packaging, Inc. · Apr 1992
OPTIMOL RESPIRATORY HUMIDIFICATION SYSTEM
K911770 · Automatic Liquid Packaging, Inc. · Oct 1991
MARQUEST SCT 3000, HEATED HUMIDIFICATION SYSTEM
K903138 · Marquest Medical Products, Inc. · Oct 1990
PRECISION MEDICAL DISPOSABLE HUMIDIFIER
K902970 · Precision Medical, Inc. · Aug 1990