510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K810999Substantially Equivalent

Cordis Tcpo2 Trancutaneous Oxygen Press

Cordis US Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810999 is the FDA 510(k) clearance record for CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS, a class II device, cleared for Cordis Corp. on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 332 510(k) clearances for Cordis US Corp., from to . As of , FDA records show no recalls naming K810999.

Clearance record

Decision date
Received
(72 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
Cordis Corp. 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