510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K101286Substantially Equivalent

Sedara Gas Mixer, Sedara Scavenger Model: 03, 04

Linde Healthcare AB, Lidingo, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101286 is the FDA 510(k) clearance record for SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04, a class II device, cleared for Linde Healthcare AB on under FDA product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation). FDA records list one 510(k) clearance for Linde Healthcare AB. As of , FDA records show no recalls naming K101286.

Clearance record

Decision date
Received
(531 days to decision)
Product code
BZR Mixer, Breathing Gases, Anesthesia Inhalation
Regulation
21 CFR 868.5330
Device class
Class II
Review panel
Anesthesiology
Applicant
Linde Healthcare AB Agavagen 54, Lidingo, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BZR

Trailing 12 months

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

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