510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K022906Substantially Equivalent

Resqpod Circulatory Enhancer

Cprx, LLC, Eden Prairie MN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022906 is the FDA 510(k) clearance record for RESQPOD CIRCULATORY ENHANCER, a class II device, cleared for Cprx, LLC on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list one 510(k) clearance for Cprx, LLC. As of , FDA records show no recalls naming K022906.

Clearance record

Decision date
Received
(281 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Cprx, LLC 7615 Golden Triangle Dr.,, Eden Prairie MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BWF

Trailing 12 months

FDA records hold no clearances under product code BWF in the trailing twelve months.

FDA records show no clearances under product code BWF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BWF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260