Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003697063

FEI Number

3003697063

Entity Name

AIRON CORPORATION

City/State/Country

Melbourne, FL, US

Establishment Address

751 North Dr Unit 6, Melbourne, FL 32934, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIRON CORPORATION (Owner Number: 9051096)

Owner / Operator Contact Address

751 North Drive, Unit 6, --, Melbourne, FL 32934, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K024344

PMA Number

N/A

All Registered Proprietary Names

pNeuton Ventilator MACS CPAP System Bacteria Filter pNeuton Mini Ventilator pNeuton Mini Neo Ventilator pNeuton Ventilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-11-20
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2008-12-09
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2008-12-09
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2016-12-05
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2012-11-30
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2007-11-20

Official Correspondent

Emilia Castellucci

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

AIRON CORPORATION

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31
K862192	U.O. Equipment Co.	RESUSCITATOR MODELS 10400/10500/10600/10700/10800	1986-07-07
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

Registration Number	Establishment Name	Location
3029922922	ORIGIN MEDICAL DEVICES HUNGARY KFT	Vac Pest, HU
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
2024500	COVIDIEN	CARLSBAD, CA, US
3001104093	DRAEGERWERK AG & CO. KGAA	LUEBECK Schleswig-Holstein, DE
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003697063. Last updated year: 2026. Please use registration number 3003697063 when referencing this establishment in official correspondence.