Cleared Traditional

K150888 - Shape-HF Cardiopulmonary Testing System (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
155d slower than avg
Panel avg: 139d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 62
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