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
K952838Substantially Equivalent

Medical Mixture-Lung Diffusion Gas Mixtures

Standard Welders Supply Co., Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952838 is the FDA 510(k) clearance record for MEDICAL MIXTURE-LUNG DIFFUSION GAS MIXTURES, a class I device, cleared for Standard Welders Supply Co. on under FDA product code BXK (Gas, Calibration (Specified Concentration)). FDA records list 3 510(k) clearances for Standard Welders Supply Co., from to . As of , FDA records show no recalls naming K952838.

Clearance record

Decision date
Received
(92 days to decision)
Product code
BXK Gas, Calibration (Specified Concentration)
Regulation
21 CFR 868.6400
Device class
Class I
Review panel
Anesthesiology
Applicant
Standard Welders Supply Co. 1259 N. Mclean, Memphis TN
510(k) summary
Statement
Third party review
No

Clearances, product code BXK

Trailing 12 months

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

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