FDA applicant
Meril Healthcare Pvt., Ltd.
FDA records 7 decisions for Meril Healthcare Pvt., Ltd. (Vapi, IN) from 2017 to 2023: 7 510(k) clearances. Most are in product codes JWH (Prosthesis, Knee, Patellofemorotibial…) and LPH (Prosthesis, Hip, Semi-Constrained…). Since 2016 its 510(k)s took a median of 211 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 46 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 Healthcare Pvt., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Meril Healthcare Pvt., Ltd.’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.