510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112634Substantially Equivalent

Natrox Topical Oxygen Delivery System with Iodp

Inotec AMD Ltd., Fairfax VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112634 is the FDA 510(k) clearance record for NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP, a class II device, cleared for Inotec Amd , Ltd. on under FDA product code KPJ (Chamber, Oxygen, Topical, Extremity). FDA records list one 510(k) clearance for Inotec Amd , Ltd. As of , FDA records show no recalls naming K112634.

Clearance record

Decision date
Received
(298 days to decision)
Product code
KPJ Chamber, Oxygen, Topical, Extremity
Regulation
21 CFR 878.5650
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Inotec Amd , Ltd. 2995 Steven Martin Dr., Fairfax VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KPJ

Trailing 12 months

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

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