FDA applicant
Vitalograph, Ltd.
FDA records 22 decisions for Vitalograph, Ltd. (Lenexa, KS) from 1979 to 2025: 22 510(k) clearances. Most are in product codes BZG (Spirometer, Diagnostic) and BZH (Meter, Peak Flow, Spirometry). Its devices cite 1 predicate, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Vitalograph, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Vitalograph, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Vitalograph, 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.