Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Thomson & Nielsen Electronics, Ltd. — Predicate Candidate Screening

4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041557MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-WThomson & Nielsen Electronics, Ltd.2004-06-25150
K032725MOSFET AUTOSENSE WIRELESSThomson & Nielsen Electronics, Ltd.2003-10-03300
K013279MOSFET AUTOSENSE, MODEL TN-RD-60Thomson & Nielsen Electronics, Ltd.2001-10-18160
K010472PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50Thomson & Nielsen Electronics, Ltd.2001-05-08770

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda