FDA applicant
Remote Diagnostic Technologies, Ltd.
FDA records 12 decisions for Remote Diagnostic Technologies, Ltd. (Hampshire, GB) from 2001 to 2020: 12 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and DXH (Transmitters And Receivers…). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 196 for FDA’s reviews in the same codes and years. Its devices cite 33 predicates, 15 of them its own earlier devices. 8 recalls are linked to its devices.
FDA’s records also spell it “Remote Diagnostic Technologies Limited”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Remote Diagnostic Technologies, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
4in 2025
Class I Class II/III not classified
Planning a device like Remote Diagnostic Technologies, 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 “Remote”
FDA records each applicant name separately; these may or may not be the same firm.