FDA applicant
Healthtek, Inc.
FDA records 9 decisions for Healthtek, Inc. (Nevada City, CA) from 1985 to 1993: 9 510(k) clearances. Most are in product codes LHI (Set, I.V. Fluid Transfer) and KPE (Container, I.V.). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Healthtek, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Healthtek, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Healthtek, Inc.’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 “Healthtek”
FDA records each applicant name separately; these may or may not be the same firm.