Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zeta Surgical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
162 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026-07-09 | 66 | 0 |
| K253663 | Zeta Navigation System | Zeta Surgical, Inc. | 2026-05-01 | 162 | 0 |
| K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025-10-10 | 109 | 0 |
| K242351 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-10-04 | 57 | 0 |
| K233903 | Zeta Cranial Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2024-01-10 | 30 | 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