510(k) Report

FDA applicant

Remote Diagnostic Technologies, Ltd. A Philips Company

Basingstoke, GB1 decision2020–20204 recalls

FDA records 1 decision for Remote Diagnostic Technologies, Ltd. A Philips Company (Basingstoke, GB) in 2020: 1 510(k) clearance. All are in product code LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 3 predicates, 0 of them its own earlier devices. 4 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Remote Diagnostic Technologies, Ltd. A Philips Company’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2020: 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

2in 2024

2020: 12023: 12024: 2
2020high 2 (2024) · low 0 (2021)2026

Class I Class II/III not classified

FIG. 1 — Remote Diagnostic Technologies, Ltd. A Philips Company by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Remote Diagnostic Technologies, Ltd. A…’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

Other applicant names beginning “Remote”

FDA records each applicant name separately; these may or may not be the same firm.