510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K893133Substantially Equivalent

Horizon 2110/Horizon 2210 264-Xxx-Xxx/261-Xxx-Xxx

Mennen Medical, Inc., Clarence NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893133 is the FDA 510(k) clearance record for HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX, a class II device, cleared for Mennen Medical, Inc. on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 55 510(k) clearances for Mennen Medical, Inc., from to . As of , FDA records show no recalls naming K893133.

Clearance record

Decision date
Received
(80 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
Mennen Medical, Inc. 10123 Main St., Clarence NY
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