Cleared Traditional

MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU (K033710) - FDA 510(k) Clearance

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

K033710 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Apr 2004
Decision
139d
Days
Class 2
Risk

K033710 is an FDA 510(k) clearance for the MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Panmure, Auckland, NZ). The FDA issued a Cleared decision on April 13, 2004 after a review of 139 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 Healthcare , Ltd. devices

Submission Details

510(k) Number K033710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date April 13, 2004
Days to Decision 139 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 139d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 51
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K033710.
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OASIS HUMIDIFIER
K964653 · Respironics, Inc. · Feb 1997