510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K080966Substantially Equivalent

Hyper-Box Topical Wound Oxygen System

Aoti, Ltd., Galway, IE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080966 is the FDA 510(k) clearance record for HYPER-BOX TOPICAL WOUND OXYGEN SYSTEM, a class II device, cleared for Aoti , Ltd. on under FDA product code KPJ (Chamber, Oxygen, Topical, Extremity). FDA records list one 510(k) clearance for Aoti , Ltd. As of , FDA records show no recalls naming K080966.

Clearance record

Decision date
Received
(124 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
Aoti , Ltd. Qualtech House, Galway, IE
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