Cleared Traditional

K090722 - SHAPE-HF CARDIOPULMONARY EXERCISE TESTI...

K090722 is an FDA 510(k) clearance for SHAPE-HF CARDIOPULMONARY EXERCISE TESTI..., manufactured by Shape Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code BTY cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K090722 · Shape Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
12d
Days
Class 2
Risk

K090722 is an FDA 510(k) clearance for the SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Shape Medical Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 31, 2009 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1890 - 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 Shape Medical Systems, Inc. devices

FDA 510(k) Submission Details - K090722

510(k) Number K090722 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date March 31, 2009
Days to Decision 12 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 140d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

BTY Device Classification - Class 2, Special Controls

Product Code BTY Calculator, Predicted Values, Pulmonary Function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1890
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 - BTY Calculator, Predicted Values, Pulmonary Function

All 18
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