510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K921565Substantially Equivalent

Cardiopulmonary Metabolic Measuement Cart

Quiton Instrument Co., Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921565 is the FDA 510(k) clearance record for CARDIOPULMONARY METABOLIC MEASUEMENT CART, a class II device, cleared for Quiton Instrument Co. on under FDA product code BZL (Computer, Oxygen-Uptake). FDA records list one 510(k) clearance for Quiton Instrument Co. As of , FDA records show no recalls naming K921565.

Clearance record

Decision date
Received
(862 days to decision)
Product code
BZL Computer, Oxygen-Uptake
Regulation
21 CFR 868.1730
Device class
Class II
Review panel
Anesthesiology
Applicant
Quiton Instrument Co. 2121 Terry Ave., Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code BZL

Trailing 12 months

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

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