Cleared Traditional

K071928 - THE INVACARE FLYER, MODEL IPC 100

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 209
Devices cleared under the same product code (CAW) and FDA review panel - the closest regulatory comparables to K071928.
A&J POCA01 OXYGEN CONCENTRATOR
K071608 · Zhongshan A&J Medical Equipment Co., Ltd. · Jan 2008
LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000
K072688 · International Biophysics Corp. · Jan 2008
PORTABLE OXYGEN CONCENTRATOR, MODEL RS-00400
K073242 · Delphi Medical Systems · Jan 2008
DEPLOYABLE OXYGEN GENERATION SYSTEM - MEDIUM (DOGS-M)
K071904 · Carleton Life Support Systems, Inc. · Oct 2007
DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES
K071397 · Sunrise Medical · Oct 2007
MODEL 300D HOME OXYGEN LIQUEFIER
K071461 · Copd Partners, Inc. · Aug 2007