Cleared Traditional

K150888 - Shape-HF Cardiopulmonary Testing System

K150888 is an FDA 510(k) clearance for Shape-HF Cardiopulmonary Testing System, 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 294-day FDA review.

K150888 · Shape Medical Systems, Inc. · Anesthesiology device
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Jan 2016
Decision
294d
Days
Class 2
Risk

K150888 is an FDA 510(k) clearance for the Shape-HF Cardiopulmonary Testing System. Classified as Calculator, Predicted Values, Pulmonary Function (product code BTY), Class II - Special Controls.

Submitted by Shape Medical Systems, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 21, 2016 after a review of 294 days - an extended review 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: 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 Shape Medical Systems, Inc. devices

FDA 510(k) Submission Details - K150888

510(k) Number K150888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2015
Decision Date January 21, 2016
Days to Decision 294 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 140d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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
Devices cleared under the same product code (BTY) and FDA review panel - the closest regulatory comparables to K150888.
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