510(k) Report

FDA applicant

M/S. Meril Life Sciences Private Limited

Chala, Vapi, IN1 decision2017–20170 recalls

FDA records 1 decision for M/S. Meril Life Sciences Private Limited (Chala, Vapi, IN) in 2017: 1 510(k) clearance. All are in product code LRC (Instrument, Ent Manual Surgical). 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, ear, nose and throat panel, where it files most

How often FDA has decided M/S. Meril Life Sciences Private Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2017: 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 — M/S. Meril Life Sciences Private Limited by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like M/S. Meril Life Sciences Private 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?

  • LRCInstrument, Ent Manual Surgical1decision

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?

  • K172737MESIRE - Balloon Sinus Dilatation SystemM/S. Meril Life Sciences Private Limited · 2017

The one decision as M/S. Meril Life Sciences Private Limited →