FDA applicant
Vitalograph (Ireland), Ltd.
FDA records 12 decisions for Vitalograph (Ireland), Ltd. (Ennis Co Clare, IE) from 2008 to 2023: 12 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and JEH (Plethysmograph, Volume). Since 2016 its 510(k)s took a median of 146 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 9 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Vitalograph Ireland, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vitalograph (Ireland), Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Vitalograph (Ireland), Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Vitalograph”
FDA records each applicant name separately; these may or may not be the same firm.