Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NOY · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203276 | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | 2021-04-20 | 165 | 0 |
| K192684 | HydroPearl Microspheres | MicroVention, Inc. | 2020-01-22 | 118 | 1 |
| K180102 | Embozene Color-Advanced Microspheres | Boston Scientific | 2018-04-19 | 93 | 0 |
| DEN160040 | Embosphere Microspheres | Biosphere Medical, S.A. | 2017-06-21 | 320 | 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