Cleared Traditional

K033710 - MR850 RESPIRATORY HUMIDIFIER

K033710 is the FDA 510(k) clearance for MR850 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 139-day FDA review.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 140d · 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 Consultant

Tuv America, Inc.
LAURA DANIELSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K033710.
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AQUINOX
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INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000
K031176 · Invacare Corp. · Mar 2004
RESPIRATORY HUMIDIFIER, MODEL MR850
K020332 · Fisher &Paykel Healthcare , Ltd. · Jul 2003
H2 HEATED HUMIDIFIER
K030090 · Respironics, Inc. · Jan 2003