Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
OrbusNeich Medical (Shenzhen) Co., Ltd. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
290 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253361 | Teleport Glide Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2026-04-10 | 192 | 0 |
| K242588 | COREPASS Modular Microcatheter (FLEX); COREPASS Modular Micr | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2025-01-07 | 130 | 0 |
| K233499 | Sapphire NC ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-16 | 290 | 0 |
| K233505 | Sapphire ULTRA Coronary Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-08-15 | 289 | 0 |
| K241025 | JADE PLUS PTA Balloon Dilatation Catheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-06-11 | 57 | 0 |
| K231608 | Teleport XT Microcatheter | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2024-01-07 | 219 | 0 |
| K211807 | Sapphire NC 24 | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-10-14 | 125 | 0 |
| K202231 | JADE | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-12-10 | 125 | 0 |
| K201794 | Jade | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2020-07-28 | 28 | 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