Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nds Surgical Imaging, LLC — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K222890 | RADIANCE ULTRA 32 4K ZEROWIRE DUO | Nds Surgical Imaging, LLC | 2022-10-19 | 26 | 0 |
| K170598 | ZeroWire Mobile | Nds Surgical Imaging, LLC | 2017-04-07 | 37 | 0 |
| K161228 | Radiance Ultra Series ZeroWire Embedded | Nds Surgical Imaging, LLC | 2016-05-26 | 24 | 0 |
| K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWir | Nds Surgical Imaging, LLC | 2015-11-06 | 144 | 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