510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103345Substantially Equivalent

Breathe Technologies Ventilator and Accessories (Bt-V2s)

Breathe Technologies, Inc., San Ramon CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103345 is the FDA 510(k) clearance record for BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S), a class II device, cleared for Breathe Technologies, Inc. on under FDA product code ONZ (Mechanical Ventilator). FDA's definition for product code ONZ reads: "This device is a volume assist ventilator intended to aid adult patients with respiratory insufficiency. It is designed for patients who are capable of spontaneously breathing a minimum tidal volume of 3.5cc/kg of predicted body weight...". FDA records list 8 510(k) clearances for Breathe Technologies, Inc., from to . As of , FDA records show no recalls naming K103345.

Clearance record

Decision date
Received
(88 days to decision)
Product code
ONZ Mechanical Ventilator
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Breathe Technologies, Inc. 4000 Executive Pkwy.,, San Ramon CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONZ

Trailing 12 months

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

FDA records show no clearances under product code ONZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONZ, 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