510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040188Substantially Equivalent

Infinity Gammaxl and Sc 6802Xl with the Scio Gas Module

Draeger Medical Systems, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040188 is the FDA 510(k) clearance record for INFINITY GAMMAXL AND SC 6802XL WITH THE SCIO GAS MODULE, a class II device, cleared for Draeger Medical Systems, Inc. on under FDA product code NHP (Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)). FDA's definition for product code NHP reads: "A sevoflurane gas analyzer is a device intended to measure the concentration of sevoflurane anesthetic in a gas mixture". FDA records list 48 510(k) clearances for Draeger Medical Systems, Inc., from to . As of , FDA records show no recalls naming K040188.

Clearance record

Decision date
Received
(77 days to decision)
Product code
NHP Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)
Regulation
21 CFR 868.1500
Device class
Class II
Review panel
Anesthesiology
Applicant
Draeger Medical Systems, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHP

Trailing 12 months

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

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