Cleared Abbreviated

K022906 - RESQPOD CIRCULATORY ENHANCER

K022906 is an FDA 510(k) clearance for RESQPOD CIRCULATORY ENHANCER, manufactured by Cprx, LLC. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Abbreviated 510(k) pathway after a 281-day FDA review.

K022906 · Cprx, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
281d
Days
Class 2
Risk

K022906 is an FDA 510(k) clearance for the RESQPOD CIRCULATORY ENHANCER. Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Cprx, LLC (Eden Prairie, US). The FDA issued a Cleared decision on June 11, 2003 after a review of 281 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K022906

510(k) Number K022906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2002
Decision Date June 11, 2003
Days to Decision 281 days
Submission Type Abbreviated
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
141d slower than avg
Panel avg: 140d · This submission: 281d
Pathway characteristics
Standards-based clearance path.

BWF Device Classification - Class 2, Special Controls

Product Code BWF Spirometer, Therapeutic (incentive)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5690
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 - BWF Spirometer, Therapeutic (incentive)

All 106
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K022906.
SPIRO-BALL
K053149 · Leventon, S.A. · Dec 2005
LIFESTYLE CIRCULATORY ENHANCER
K040084 · Advanced Circulatory Systems, Inc. · Apr 2004
MODIFICATION TO RESQPOD CIRCULATORY ENHANCER
K033401 · Advanced Circulatory Systems, Inc. · Nov 2003
AEROPEP
K012368 · Trudell Medical Intl. · Feb 2002
ACAPELLA
K002768 · Dhd Healthcare Corp. · Dec 2000
CLINIFLO INCENTIVE SPIROMETER
K003146 · Dhd Healthcare Corp. · Nov 2000
K022906 · RESQPOD CIRCULATORY ENHANCER
Download PDF FDA Summary Cprx, LLC