510(k) Report

FDA applicant

Healthium Medtech Limited

Bangalore, IN5 decisions2023–20240 recalls

FDA records 5 decisions for Healthium Medtech Limited (Bangalore, IN) from 2023 to 2024: 5 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 57 for FDA’s reviews in the same codes and years. Its devices cite 8 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2024

2023: 42024: 1
2023high 4 (2023) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Healthium Medtech Limited by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Healthium Medtech Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MBIFastener, Fixation, Nondegradable, Soft Tissue5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 85 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 57 days; 1 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231033CEPTRE® Knotted UHMWPE Suture PEEK AnchorHealthium Medtech Limited · 2024
  • K230891SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair ImplantHealthium Medtech Limited · 2023
  • K232886INFILOOP® Fixed Loop UHMWPE Suture Titanium ButtonHealthium Medtech Limited · 2023
  • K231404T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE…Healthium Medtech Limited · 2023
  • K223889Stativ® Knotted UHMWPE Suture AnchorHealthium Medtech Limited · 2023

All 5 as Healthium Medtech Limited →