FDA applicant
Meril Life Sciences Private Limited
FDA records 4 decisions for Meril Life Sciences Private Limited (Vapi, IN) from 2013 to 2019: 4 510(k) clearances. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and QEZ (Aspiration Thrombectomy Catheter). Since 2016 its 510(k)s took a median of 49 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 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
How often FDA has decided Meril Life Sciences Private Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2013.
Planning a device like 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) ReportOther applicant names beginning “Meril”
FDA records each applicant name separately; these may or may not be the same firm.