510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090722Substantially Equivalent

Shape-HF Cardiopulmonary Exercise Testing System

Shape Medical Systems, Inc, Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090722 is the FDA 510(k) clearance record for SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM, a class II device, cleared for Shape Medical Systems, Inc. on under FDA product code BTY (Calculator, Predicted Values, Pulmonary Function). FDA records list 2 510(k) clearances for Shape Medical Systems, Inc., from to . As of , FDA records show 2 recalls naming K090722.

Clearance record

Decision date
Received
(12 days to decision)
Product code
BTY Calculator, Predicted Values, Pulmonary Function
Regulation
21 CFR 868.1890
Device class
Class II
Review panel
Anesthesiology
Applicant
Shape Medical Systems, Inc. 1313 5th Ave. SE, Minneapolis MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BTY

Trailing 12 months
1 clearance under product code BTY in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code BTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260