510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K923397Substantially Equivalent

Single Dose Gas Injector

Escalon Medical Trek, Mukwonago WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923397 is the FDA 510(k) clearance record for SINGLE DOSE GAS INJECTOR, a class I device, cleared for Escalon Medical Trek on under FDA product code BXX (Calibrator, Pressure, Gas). FDA records list one 510(k) clearance for Escalon Medical Trek. As of , FDA records show no recalls naming K923397.

Clearance record

Decision date
Received
(66 days to decision)
Product code
BXX Calibrator, Pressure, Gas
Regulation
21 CFR 868.2620
Device class
Class I
Review panel
Anesthesiology
Applicant
Escalon Medical Trek 820 Swan Dr., Mukwonago WI
510(k) summary
Statement
Third party review
No

Clearances, product code BXX

Trailing 12 months

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

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