Cleared Traditional

K060044 - ACUTE CARE FACE MASK, MODEL RT040

K060044 is an FDA 510(k) clearance for ACUTE CARE FACE MASK, manufactured by Fisher &Paykel Healthcare , Ltd.. The device is a Class 2 Anesthesiology device with product code MNT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K060044 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
90d
Days
Class 2
Risk

K060044 is an FDA 510(k) clearance for the ACUTE CARE FACE MASK, MODEL RT040. Classified as Ventilator, Continuous, Minimal Ventilatory Support, Facility Use (product code MNT), Class II - Special Controls.

Submitted by Fisher &Paykel Healthcare , Ltd. (Panmure, Auckland, NZ). The FDA issued a Cleared decision on April 6, 2006 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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

FDA 510(k) Submission Details - K060044

510(k) Number K060044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2006
Decision Date April 06, 2006
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNT Device Classification - Class 2, Special Controls

Product Code MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - MNT Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

All 22
Devices cleared under the same product code (MNT) and FDA review panel - the closest regulatory comparables to K060044.
BREAS VIVO 40 SYSTEM
K090113 · Breas Medical AB · May 2009
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K082660 · Respironics California, Inc. · Jan 2009
BREAS VIVO BILEVEL SYSTEM, MODEL VIVO 40
K071702 · Breas Medical AB · Feb 2008
BREAS VIVO 40 SYSTEM
K053607 · Breas Medical AB · Mar 2006
STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964
K990574 · Respironics, Inc. · May 1999
BIPAP VISION VENTILATORY SUPPORT
K982454 · Respironics, Inc. · Nov 1998