Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Orbusneich Medical Trading, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
257 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200269 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2020-03-04 | 29 | 0 |
| K192344 | Sapphire NC Plus Coronary Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2019-09-19 | 21 | 0 |
| K182713 | Scoreflex PTA Scoring Balloon Catheter | Orbusneich Medical Trading, Inc. | 2019-06-11 | 257 | 0 |
| K182360 | Teleport Microcatheter | Orbusneich Medical Trading, Inc. | 2018-11-09 | 71 | 0 |
| K180921 | Sapphire II PRO Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-06-28 | 80 | 0 |
| K173680 | Sapphire II PRO | Orbusneich Medical Trading, Inc. | 2018-03-01 | 90 | 0 |
| K173894 | Jade PTA Balloon Dilatation Catheter | Orbusneich Medical Trading, Inc. | 2018-02-09 | 50 | 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