Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Natus Neurology Incorporated · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
80 daysmedian FDA review time
267 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243982 | Nicolet EDX | Natus Neurology Incorporated | 2025-01-22 | 30 | 0 |
| K243495 | Natus Ultrapro S100 (982A0594) | Natus Neurology Incorporated | 2024-12-12 | 30 | 0 |
| K173366 | NicoletOne | Natus Neurology Incorporated | 2018-07-20 | 267 | 0 |
| K172743 | Natus VikingQuest | Natus Neurology Incorporated | 2017-12-19 | 98 | 0 |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | Natus Neurology Incorporated | 2013-05-02 | 80 | 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