Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Scion Medical Technologies, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
49 daysmedian FDA review time
100 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170905 | Star Tissue Marker | Scion Medical Technologies, LLC | 2017-04-27 | 30 | 0 |
| K161234 | CASSI II Rotational Core Biopsy System | Scion Medical Technologies, LLC | 2016-08-03 | 93 | 0 |
| K153189 | Beacon Tissue Marker (SE) | Scion Medical Technologies, LLC | 2015-12-17 | 44 | 0 |
| K140835 | GENERAL AND PLASTIC SURGERY | Scion Medical Technologies, LLC | 2014-05-20 | 48 | 0 |
| K130763 | BEACON TISSUE MARKER | Scion Medical Technologies, LLC | 2013-05-08 | 49 | 0 |
| K123606 | CASSI II ROTATIONAL CORE BIOPSY SYSTEM; CASSI QUADPOINT DISP | Scion Medical Technologies, LLC | 2013-03-01 | 100 | 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