# Vitalograph (Ireland), Ltd.

- Location (FDA's records): Ennis Co Clare, IE
- FDA decisions: 12 (2008–2023): 12 510(k) clearances
- Names in FDA's records: Vitalograph (Ireland) , Ltd. (7); Vitalograph Ireland, Ltd. (5)
- Product codes: BZG (9), JEH (1), DSH (1), BTY (1)
- 510(k) review time since 2016: median 146 days, against 126 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 18 (9 its own); citations of its devices by later devices: 14 (9 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Morgan Scientific, Inc.: 1 (https://510kreport.com/company/morgan-scientific)
- Micro Medical, Ltd.: 1 (https://510kreport.com/company/micro-medical)
- Karmelsonix: 1 (https://510kreport.com/company/karmelsonix)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)
- Medical International Research USA, Inc.: 1 (https://510kreport.com/company/medical-international-research-usa)
- Vitalograph, Ltd.: 1 (https://510kreport.com/company/vitalograph)
- Viasys Healthcare GmbH: 1 (https://510kreport.com/company/viasys-healthcare)
- Pulmonary Data Services, Inc.: 1 (https://510kreport.com/company/pulmonary-data-services)

## Firms that cite its devices most
- Vitalograph, Ltd.: 1 (https://510kreport.com/company/vitalograph)
- Mesi D.O.O.: 1 (https://510kreport.com/company/mesi-doo)
- Strados Labs, Inc.: 1 (https://510kreport.com/company/strados-labs)
- Pmd Healthcare: 1 (https://510kreport.com/company/pmd-healthcare)
- Gostar Co., Ltd.: 1 (https://510kreport.com/company/gostar)

## Its most-cited devices
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), cited by 4
- K073155: Vitalograph Model 4000 (Asma-1 and Copd-6) (2008), cited by 2
- K110525: Vitalograph Model 7100 - Vitalojak (2011), cited by 2
- K141546: Vitalograph Model 7000 Spirotrac (2014), cited by 2
- K142812: Vitalograph Model 6800 Pneumotrac (2015), cited by 1
- K212938: Vitalograph Model 6000 Alpha (2022), cited by 1

## Recent decisions
- K223818: Model 9160 VitaloQUB (May 25, 2023)
- K221030: Model 9100 PFT/DICO (Jul 15, 2022)
- K212938: Vitalograph Model 6000 Alpha (Jan 26, 2022)
- K201562: Spirotrac (Oct 14, 2020)
- K200550: Vitalograph Model 2120 In2itive eDiary (Jul 27, 2020)
- K160253: Vitalograph Model 6300 micro (Aug 26, 2016)
- K142642: Vitalograph Model 6600 Compact (Jun 30, 2015)
- K142812: Vitalograph Model 6800 Pneumotrac (Jun 29, 2015)

Source page: https://510kreport.com/company/vitalograph-ireland