Cleared Traditional

K062019 - RESPCARE HYBRID NE FACE MASK

Also marketed or referenced as:
DISPOSABLE, MODEL TBD

K062019 is an FDA 510(k) clearance for RESPCARE HYBRID NE FACE MASK, manufactured by Innomed Technologies, Inc./Respcare, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K062019 · Innomed Technologies, Inc./Respcare, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
31d
Days
Class 2
Risk

K062019 is an FDA 510(k) clearance for the RESPCARE HYBRID NE FACE MASK, MODEL TBD,. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Innomed Technologies, Inc./Respcare, Inc. (Coconut Creek, US). The FDA issued a Cleared decision on August 17, 2006 after a review of 31 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innomed Technologies, Inc./Respcare, Inc. devices

FDA 510(k) Submission Details - K062019

510(k) Number K062019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2006
Decision Date August 17, 2006
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, 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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K062019.
VENTILATOR WITH RESPIRATORY MECHANICS, MODEL 840
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GE DATEX-OHMEDA ENGSTROM CARESTATION
K062710 · Datex-Ohmeda, Inc. · Dec 2006
NEWPORT E500 WAVE VENTILATOR
K061094 · Newport Medical Instruments, Inc. · Jul 2006
GALILEO GOLD ASV
K061090 · Hamilton Medical AG · Jul 2006
GE DATEX-OHMEDA ENGSTROM CARESTATION
K060862 · Datex-Ohmeda, Inc. · Jun 2006