Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nds Surgical Imaging — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
148 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K133609 | THE DOME S6C | Nds Surgical Imaging | 2014-02-28 | 95 | 0 |
| K132770 | DOME S10 | Nds Surgical Imaging | 2014-01-30 | 148 | 0 |
| K131115 | ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE | Nds Surgical Imaging | 2013-06-07 | 49 | 0 |
| K120709 | THE DOME GX4MP COLOR NONITOR | Nds Surgical Imaging | 2012-04-06 | 29 | 0 |
| K100195 | NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD V | Nds Surgical Imaging | 2010-04-21 | 89 | 0 |
| K080320 | PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 | Nds Surgical Imaging | 2008-02-21 | 15 | 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