FDA applicant

Allengers Medical Systems Limited

Derabassi, Distt Mohali, IN8 decisions2017–20260 recalls

FDA records 8 decisions for Allengers Medical Systems Limited (Derabassi, Distt Mohali, IN) from 2017 to 2026: 8 510(k) clearances. Most are in product codes KPR (System, X-Ray, Stationary) and OWB (Interventional Fluoroscopic X-Ray System). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 53 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 4 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 Allengers Medical Systems Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017high 3 (2022) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

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

Planning a device like Allengers Medical Systems 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

Other applicant names beginning “Allengers”

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

Allengers Global Healthcare Private Limited 2

Allengers Medical Systems Limited

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Allengers”