Meril Healthcare Pvt. , Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Meril Healthcare Pvt. , Ltd.” (first 2017, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 211 days. Since 2017 the median was 211 days, against 96 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 65 |
| 2018 | 2 | 305 |
| 2019 | 1 | 211 |
| 2020 | 0 | — |
| 2021 | 1 | 70 |
| 2022 | 1 | 60 |
| 2023 | 1 | 270 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Meril Healthcare Pvt. , Ltd. took a median 211 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 96 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Meril Healthcare Pvt. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222436 | Latitud Hip Replacement System | LPH | 2023-05-09 | 270 |
| K222816 | Opulent TiNbN Coated Knee | JWH | 2022-11-18 | 60 |
| K212839 | Opulent TiNbN Coated Knee | JWH | 2021-11-16 | 70 |
| K183532 | Latitud Hip Replacement System | LZO | 2019-07-18 | 211 |
| K172857 | Latitud Hip Replacement System | LPH | 2018-07-19 | 302 |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws | HRS | 2018-03-08 | 308 |
| K172936 | Destiknee Total Knee System | JWH | 2017-11-30 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Meril Healthcare Pvt. , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Meril Life Sciences Private Limited (4 510(k)s)
- Meril Healthcare Private Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Meril Healthcare Pvt. , Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Meril Healthcare Pvt. , Ltd.” (first 2017, latest 2023), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Meril Healthcare Pvt. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Meril Healthcare Pvt. , Ltd. is 211 days. Since 2017: 211 days, versus 96 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Meril Healthcare Pvt. , Ltd.?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 3); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2); HRS (Plate, Fixation, Bone, 1).
Next steps
- See all 7 Meril Healthcare Pvt. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JWH, Meril Healthcare Pvt. , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.