Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OVB — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
83 daysmedian FDA review time
332 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260119 | SpaceOAR Vue System (SV-2101) | Boston Scientific Corporation | 2026-02-10 | 27 | 0 |
| K222972 | BioProtect Balloon Implantâ„¢ System | Bioprotect, Ltd. | 2023-08-25 | 332 | 0 |
| K220641 | Barrigel Injectable Gel | Palette Life Sciences | 2022-05-26 | 83 | 0 |
| K202224 | SpaceOAR System | Boston Scientific Corporation | 2020-08-28 | 21 | 0 |
| K182971 | SpaceOAR Vue Hydrogel | Augmenix, Inc. | 2019-07-19 | 266 | 0 |
| K181465 | SpaceOAR System | Augmenix, Inc. | 2018-06-25 | 21 | 0 |
| DEN140030 | SpaceOAR System | Augmenix, Inc. | 2015-04-01 | 182 | 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