Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Meril Healthcare Pvt. , Ltd. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
211 daysmedian FDA review time
308 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222436 | Latitud™ Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2023-05-09 | 270 | 0 |
| K222816 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | 2022-11-18 | 60 | 0 |
| K212839 | Opulent TiNbN Coated Knee | Meril Healthcare Pvt. , Ltd. | 2021-11-16 | 70 | 0 |
| K183532 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2019-07-18 | 211 | 0 |
| K172857 | Latitud Hip Replacement System | Meril Healthcare Pvt. , Ltd. | 2018-07-19 | 302 | 0 |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / | Meril Healthcare Pvt. , Ltd. | 2018-03-08 | 308 | 0 |
| K172936 | Destiknee™ Total Knee System | Meril Healthcare Pvt. , Ltd. | 2017-11-30 | 65 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda