Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006538358

FEI Number

3006538358

Entity Name

AOTI LTD.

City/State/Country

GALWAY, IE

Establishment Address

Unit 20 Glenrock Business Park, Ballybane, GALWAY --, IE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

AOTI LTD. (Owner Number: 9099459)

Owner / Operator Contact Address

Unit 20 Glenrock Business Park, Ballybane, Galway, IE-G H91 N23C, IE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K162610

PMA Number

N/A

All Registered Proprietary Names

Hyper-Box System Topical Wound Oxygen Multi-Patch NEXA NPWT System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2024-01-23
KPJ	Chamber, Oxygen, Topical, Extremity	General, Plastic Surgery	Class 2	878.5650	2007-03-23
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2024-06-20

Official Correspondent

No official correspondent registered.

US Agent Details

MIKE GRIFFITHS Business: AOTI Email: mike.griffiths@aotinc.net Phone: (760) 6721920

Related Public Records

Same Entity

AOTI LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2013	Accuro Medical Product LLC	2	Wound Pro Apex Negative Pressure Wound Therapy Powered Suction Pump; Accuro Medical Products LLC, 2854 Hitchcock Ave, Downers Grove, IL 60515; part number 84635400182, sold inside the Apex Negative Wound Therapy system, part number 84635400181 Promotes wound healing through drainage and removal of infectious material and other fluids from the wound site using continuous and/or intermittent negative pressure. Types of wounds indicated include diabetic/neuropathic ulcers, pressure ulcers, chronic wounds, acute wounds and dehisced wounds.
Z-0039-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 250 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0040-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).
Z-0041-2015	Smith & Nephew, Inc.	2	RENASYS EZ/ RENASYS EZ Plus 800 mL canister (w/o CLP) with Solidifier Product Usage: RENASYS EZ and RENASYS EZ Plus Canisters are used for the collection of exudate removed from wounds being treated by negative pressure wound therapy (NPWT).

Similar Registrations

Registration Number	Establishment Name	Location
3005144609	EPTAM PLASTICS, LTD	Northfield, NH, US
3008847017	GWR MEDICAL, INC.	Chadds Ford, PA, US
3008139322	ELECTROCHEMICAL OXYGEN CONCEPTS	San Antonio, TX, US
3038429246	EPTAM PRECISION MOLDING MA (A DIVISION OF EPTAM PRECISION)	Lancaster, MA, US
3004727093	IIMED MEDICAL MEXICANA S. DE R.L. DE C.V.	Reynosa Tamaulipas, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006538358. Last updated year: 2026. Please use registration number 3006538358 when referencing this establishment in official correspondence.