510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K851288Substantially Equivalent

Oxygen Delivery Measuring Device

Bar-Dix, Inc., Frazee MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851288 is the FDA 510(k) clearance record for OXYGEN DELIVERY MEASURING DEVICE, a class I device, cleared for Bar-Dix, Inc. on under FDA product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated). FDA records list one 510(k) clearance for Bar-Dix, Inc. As of , FDA records show no recalls naming K851288.

Clearance record

Decision date
Received
(155 days to decision)
Product code
CAX Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Regulation
21 CFR 868.2340
Device class
Class I
Review panel
Anesthesiology
Applicant
Bar-Dix, Inc. Rural Rte. Box 65, Frazee MN
Third party review
No

Clearances, product code CAX

Trailing 12 months

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

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