FDA applicant
Promedtek, Inc.
FDA records 2 decisions for Promedtek, Inc. (Washington, DC) from 2007 to 2016: 2 510(k) clearances. Most are in product codes ILX (Diathermy, Shortwave, For Use Other Than…) and IMJ (Diathermy, Shortwave, For Use In Applying…). 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 Promedtek, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2016
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Promedtek, 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