Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Niti Medical Technologies , Ltd. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
79 daysmedian FDA review time
208 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062008 | ENDO CAR COMPRESSION ANASTOMOSIS RING (CAR) | Niti Medical Technologies , Ltd. | 2006-08-09 | 23 | 0 |
| K050356 | COMPRESSION ANASTOMOSIS RING (CAR) | Niti Medical Technologies , Ltd. | 2005-05-05 | 80 | 0 |
| K043115 | LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) | Niti Medical Technologies , Ltd. | 2004-12-01 | 21 | 0 |
| K042492 | HAND STC, MODEL 60MM | Niti Medical Technologies , Ltd. | 2004-10-19 | 35 | 0 |
| K041751 | COMPRESSION ANASTOMOSIS CLIP (CAC) | Niti Medical Technologies , Ltd. | 2004-09-16 | 79 | 0 |
| K033324 | COMPRESSION ANASTOMOSIS CLIP (CAC) | Niti Medical Technologies , Ltd. | 2004-05-10 | 208 | 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