FDA applicant
Howtek, Inc.
FDA records 5 decisions for Howtek, Inc. (Hudson, NH) from 1996 to 2002: 5 510(k) clearances. Most are in product codes LMA (Digitizer, Image, Radiological) and LMD (System, Digital Image Communications…). Its devices cite 2 predicates, 0 of them its own earlier devices. 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 Howtek, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Howtek, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Howtek, 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) Report