Data / Medical devices / Ireland / Vitalograph Ireland Ltd.

Vitalograph Ireland Ltd.: FDA-registered device maker in Co Clare, Ireland, 21 510(k) clearances

Name: Vitalograph Ireland Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vitalograph Ireland Ltd. is registered with the FDA (registration 3002808458) in Co Clare, Ireland. It lists 11 device types. The FDA files 21 510(k) clearances under its listings, the newest dated December 3, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3002808458
Address: Gort Road Business Park Ennis, Co Clare, Ireland, Eire
Owner or operator: Vitalograph Ireland Ltd. (10024235)
Roles: Manufacturer, Specification developer
First device listed: January 14, 2008
Registered through: 2026
Brand names listed: Alpha, BT12 ECG, Bacterial/Viral Filter {BVF}, ComPas2, Compas, Model 2120 In2itive eDiary, Model 6300 micro, Model 7000 Spirotrac and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase	CCJ	2	Manufacturer	accessdata.fda.gov
Calculator, Predicted Values, Pulmonary Function	BTY	2	Manufacturer	accessdata.fda.gov
Calibrator, Volume, Gas	BXW	1	Manufacturer	accessdata.fda.gov
Clip, Nose	BXJ	1	Manufacturer	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Manufacturer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Manufacturer	accessdata.fda.gov
Plethysmograph, Volume	JEH	2	Manufacturer	accessdata.fda.gov
Recorder, Magnetic Tape, Medical	DSH	2	Manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Manufacturer	accessdata.fda.gov
Spirometer, Therapeutic (Incentive)	BWF	2	Manufacturer	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 3, 2025	K253293	VitaloJAK Clinic (Model 7100)	DSH	Substantially Equivalent	Vitalograph , Ltd.	accessdata.fda.gov
May 25, 2023	K223818	Model 9160 VitaloQUB	JEH	Substantially Equivalent	Vitalograph Ireland, Ltd.	accessdata.fda.gov
July 15, 2022	K221030	Model 9100 PFT/DICO	BTY	Substantially Equivalent	Vitalograph Ireland, Ltd.	accessdata.fda.gov
July 15, 2022	K213872	ComPAS2	BZG	Substantially Equivalent	Morgan Scientific, Inc.	accessdata.fda.gov
January 26, 2022	K212938	Vitalograph Model 6000 Alpha	BZG	Substantially Equivalent	Vitalograph Ireland, Ltd.	accessdata.fda.gov
October 14, 2020	K201562	Spirotrac	BZG	Substantially Equivalent	Vitalograph Ireland, Ltd.	accessdata.fda.gov
July 27, 2020	K200550	Vitalograph Model 2120 In2itive eDiary	BZG	Substantially Equivalent	Vitalograph Ireland, Ltd.	accessdata.fda.gov
June 6, 2019	K190568	ComPAS2 (Computerized Pulmonary Analysis System)	BZG	Substantially Equivalent	Morgan Scientific, Inc.	accessdata.fda.gov
August 26, 2016	K160253	Vitalograph Model 6300 micro	BZG	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
June 30, 2015	K142642	Vitalograph Model 6600 Compact	BZG	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
June 29, 2015	K142812	Vitalograph Model 6800 Pneumotrac	BZG	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
September 3, 2014	K141546	VITALOGRAPH MODEL 7000 SPIROTRAC	BZG	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
November 23, 2011	K110525	VITALOGRAPH MODEL 7100 - VITALOJAK	DSH	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
October 16, 2010	K100687	VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120	BZG	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
September 2, 2008	K082077	BT3/6, BT12	DXH	Substantially Equivalent	Corscience GmbH & Co. KG	accessdata.fda.gov
June 4, 2008	K073155	VITALOGRAPH MODEL 4000 (ASMA-1 AND COPD-6)	BZG	Substantially Equivalent	Vitalograph (Ireland) , Ltd.	accessdata.fda.gov
October 18, 2002	K021200	COMPAS	BZG	Substantially Equivalent	Morgan Scientific, Inc.	accessdata.fda.gov
July 13, 1994	K942779	DISPOSABLE BACTERIOLOGICAL FILTER	BZG	Substantially Equivalent	Vitalograph, Inc.	accessdata.fda.gov
August 21, 1989	K893665	AEROSOL INHALATION MONITOR	BWF	Substantially Equivalent	Vitalograph , Ltd.	accessdata.fda.gov
May 5, 1989	K892524	VITALOGRAPH-BREATHCO MONITOR	CCJ	Substantially Equivalent	Vitalograph , Ltd.	accessdata.fda.gov
February 13, 1979	K781922	PULMONARY MONITOR	BZH	Substantially Equivalent	Vitalograph , Ltd.	accessdata.fda.gov

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Updated December 3, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.