Cleared Traditional

K071928 - THE INVACARE FLYER

K071928 is an FDA 510(k) clearance for THE INVACARE FLYER, manufactured by Invacare Corp.. The device is a Class 2 Anesthesiology device with product code CAW cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K071928 · Invacare Corp. · Anesthesiology device
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Dec 2007
Decision
153d
Days
Class 2
Risk

K071928 is an FDA 510(k) clearance for the THE INVACARE FLYER, MODEL IPC 100. Classified as Generator, Oxygen, Portable within the CAW classification (a category for home-use oxygen therapy and respiratory devices), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on December 12, 2007 after a review of 153 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5440 - 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 Invacare Corp. devices

FDA 510(k) Submission Details - K071928

510(k) Number K071928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2007
Decision Date December 12, 2007
Days to Decision 153 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
13d slower than avg
Panel avg: 140d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAW Device Classification - Class 2, Special Controls

Product Code CAW Generator, Oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5440
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 - CAW Generator, Oxygen, Portable

All 91
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K071928.
OMNI 5 TOTAL O2 DELIVERY SYSTEM
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HOMELOX
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L4 OXYGEN CONCENTRATOR
K061261 · Respironics, Inc. · Jun 2006
MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600
K043006 · Respironics, Inc. · Feb 2005
VENTURE HOMEFILL II WITH OXYGEN CONSERVER
K021685 · Invacare Corp. · Jul 2002