Cleared Traditional

K070490 - CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR)

K070490 is an FDA 510(k) clearance for CIRQLATOR INTRATHORACIC PRESSURE REGULA..., manufactured by Advanced Circulatory Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BWF cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K070490 · Advanced Circulatory Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
120d
Days
Class 2
Risk

K070490 is an FDA 510(k) clearance for the CIRQLATOR INTRATHORACIC PRESSURE REGULATOR (ITPR). Classified as Spirometer, Therapeutic (incentive) (product code BWF), Class II - Special Controls.

Submitted by Advanced Circulatory Systems, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 20, 2007 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5690 - 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.

FDA 510(k) Submission Details - K070490

510(k) Number K070490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2007
Decision Date June 20, 2007
Days to Decision 120 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
20d faster than avg
Panel avg: 140d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 79
Devices cleared under the same product code (BWF) and FDA review panel - the closest regulatory comparables to K070490.
LUNG FLUTE THERAPEUTIC
K091557 · Medical Acoustics · Jan 2010
PARI PEP S
K090829 · Pari Respiratory Equipment, Inc. · Jul 2009
RESPIFIT S, MODEL RS-LR1001004
K080299 · Eumedics Medizintechnik Und Marketing GmbH · Jan 2009
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