510(k) Report

FDA applicant

Philips India Limited

Pune, IN2 decisions2017–20210 recalls

FDA records 2 decisions for Philips India Limited (Pune, IN) from 2017 to 2021: 2 510(k) clearances. Most are in product codes IZL (System, X-Ray, Mobile) and OWB (Interventional Fluoroscopic X-Ray System). 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, last Nov 3, 2026

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

How often FDA has decided Philips India Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2017: 12021: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Philips India Limited by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Philips India Limited’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

Which product codes does it file in?

  • IZLSystem, X-Ray, Mobile1decision
  • OWBInterventional Fluoroscopic X-Ray System1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K203623StentBoost MobilePhilips India Limited · 2021
  • K173187MobileDiagnost M50Philips India Limited · 2017

All 2 as Philips India Limited →