510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222018Substantially Equivalent

Breathe+

Peep Medical, LLC dba Go2 Devices, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222018 is the FDA 510(k) clearance record for Breathe+, a class II device, cleared for Peep Medical, LLC Dba Go2 Devices on under FDA product code BWF (Spirometer, Therapeutic (Incentive)). FDA records list one 510(k) clearance for Peep Medical, LLC Dba Go2 Devices. As of , FDA records show no recalls naming K222018.

Clearance record

Decision date
Received
(329 days to decision)
Product code
BWF Spirometer, Therapeutic (Incentive)
Regulation
21 CFR 868.5690
Device class
Class II
Review panel
Anesthesiology
Applicant
Peep Medical, LLC Dba Go2 Devices 9230 Katy Fwy., Suite 600, Houston TX
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