Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek): FDA clearances and approvals
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) has 12 FDA 510(k) clearances (first 2016, latest 2024), across 8 product codes in 2 review panels. Median 510(k) review time: 77 days. Since 2017 its median was 98 days, against 150 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 3 | 50 |
| 2017 | 1 | 56 |
| 2018 | 4 | 116 |
| 2019 | 0 | — |
| 2020 | 1 | 46 |
| 2021 | 1 | 134 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 86 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)'s cleared 510(k)s took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 3 | 3 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 2 | 2 |
| GWE | Stimulator, Photic, Evoked Response | 1 | 1 |
| GWJ | Stimulator, Auditory, Evoked Response | 1 | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
| OMC | Reduced- Montage Standard Electroencephalograph | 1 | 1 |
Review panels
- Neurology (11)
- Ophthalmic (1)
Most recent Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242930 | Natus BrainWatch System | OMC | 2024-11-19 | 56 |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | GWJ | 2024-03-08 | 115 |
| K203500 | RetCam Envision | HKI | 2021-04-13 | 134 |
| K200878 | Natus NeuroWorks | OMB | 2020-05-18 | 46 |
| K173936 | Natus Photic Stimulator | GWE | 2018-06-15 | 171 |
| K180290 | Natus Brain Monitor Amplifier | GWQ | 2018-06-14 | 133 |
| K180421 | Natus NeuroWorks | OMB | 2018-03-14 | 26 |
| K173690 | Grass TWin | OLV | 2018-03-09 | 98 |
| K172711 | Comet-PLUS | OLV | 2017-11-03 | 56 |
| K163163 | XLTEK EMU40EX EEG Headbox | GWQ | 2016-12-14 | 34 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) have?
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) has 12 FDA 510(k) clearances (first 2016, latest 2024), across 8 product codes in 2 review panels.
How long does FDA take to clear Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)'s 510(k)s?
The median time from FDA receipt to decision across Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)'s cleared 510(k)s is 77 days. Since 2017: 98 days, versus 150 days for all cleared 510(k)s in the same product codes.
What devices does Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) make?
Its most frequent FDA product codes are GWQ (Full-Montage Standard Electroencephalograph, 3); OLV (Standard Polysomnograph With Electroencephalograph, 2); OMB (Automatic Event Detection Software For Full-Montage Electroencephalograph, 2).
Has Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) had device recalls?
openFDA lists no recalls under a recalling firm name matching Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Related entities may recall under other names.
Next steps
- See all 12 Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.