Natus Neurology Incorporated: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Natus Neurology Incorporated” (first 2013, latest 2025), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 64 days, against 154 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 80 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 98 |
| 2018 | 1 | 267 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 30 |
| 2025 | 1 | 30 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Natus Neurology Incorporated took a median 64 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 154 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 3 | 3 |
| IKN | Electromyograph, Diagnostic | 1 | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
- Neurology (5)
Most recent Natus Neurology Incorporated 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243982 | Nicolet EDX | GWF | 2025-01-22 | 30 |
| K243495 | Natus Ultrapro S100 (982A0594) | GWF | 2024-12-12 | 30 |
| K173366 | NicoletOne | OLZ | 2018-07-20 | 267 |
| K172743 | Natus VikingQuest | IKN | 2017-12-19 | 98 |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | GWF | 2013-05-02 | 80 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2013-02-27.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Natus Medical, Inc. (12 510(k)s)
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (12 510(k)s)
- Natus Medical Incorporated (10 510(k)s)
- Natus Manufacturing Limited (4 510(k)s)
- Natus Medical Denmark Aps (1 510(k)s)
- Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) (1 510(k)s)
- Natus Nicolet Ireland, Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Natus Neurology Incorporated?
FDA lists 5 510(k) clearances under the applicant name “Natus Neurology Incorporated” (first 2013, latest 2025), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Natus Neurology Incorporated?
The median time from FDA receipt to decision across 510(k)s cleared under the name Natus Neurology Incorporated is 80 days. Since 2017: 64 days, versus 154 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Natus Neurology Incorporated?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 3); IKN (Electromyograph, Diagnostic, 1); OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph, 1).
Next steps
- See all 5 Natus Neurology Incorporated clearances with predicates and recalls
- Run predicate analysis for product code GWF, Natus Neurology Incorporated's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.