510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800631Substantially Equivalent

Oxymeter

Dragerwerk AG, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800631 is the FDA 510(k) clearance record for OXYMETER, a class II device, cleared for Dragerwerk AG on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 3 510(k) clearances for Dragerwerk AG, from to . As of , FDA records show no recalls naming K800631.

Clearance record

Decision date
Received
(13 days to decision)
Product code
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Applicant
Dragerwerk AG 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KLK

Trailing 12 months

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

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