Excel-Tech Ltd. (Xltek): FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Excel-Tech Ltd. (Xltek)” (first 2008, latest 2014), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 253 days. 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 |
|---|---|---|
| 2012 | 1 | 154 |
| 2013 | 1 | 219 |
| 2014 | 1 | 287 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWQ | Full-Montage Standard Electroencephalograph | 2 | 2 |
| OLX | Source Localization Software For Electroencephalograph Or Magnetoencephalograph | 1 | 1 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 1 | 1 |
| OMA | Amplitude-Integrated Electroencephalograph | 1 | 1 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 1 | 1 |
Review panels
- Neurology (6)
Most recent Excel-Tech Ltd. (Xltek) 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K131266 | TREZ_HD | GWQ | 2014-02-14 | 287 |
| K123079 | OLYMPIC BRAINZ MONITOR | OMA | 2013-05-08 | 219 |
| K120260 | ICTA | OMB | 2012-06-29 | 154 |
| K090277 | NATUS SLEEPWORKS, MODEL 104017 | OLZ | 2011-04-19 | 804 |
| K100126 | STELLATE GRIDVIEW | OLX | 2010-12-03 | 318 |
| K081741 | NEUROLINK IP, MODEL PK1113 | GWQ | 2008-10-31 | 134 |
Recalls
openFDA lists no recalls under a recalling firm named Excel-Tech Ltd. (Xltek).
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.
- Excel Tech. , Ltd. (58 510(k)s)
- Excel Scientific, Inc. (8 510(k)s)
- Excel Health Care Products (5 510(k)s)
- Excel Medical, Inc. (5 510(k)s)
- Excel U.S.A. (3 510(k)s)
- Excel Medical Products, Inc. (2 510(k)s)
- Excel Mobility Products, Inc. (2 510(k)s)
- Excel Eyewear Corp. (1 510(k)s)
- Excel Glove Co., Ltd. (1 510(k)s)
- Excel Medical Electronics, LLC (1 510(k)s)
- Excel Medical Systems, Inc. (1 510(k)s)
- Excel Porcelain Products (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Excel-Tech Ltd. (Xltek)?
FDA lists 6 510(k) clearances under the applicant name “Excel-Tech Ltd. (Xltek)” (first 2008, latest 2014), across 5 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 Excel-Tech Ltd. (Xltek)?
The median time from FDA receipt to decision across 510(k)s cleared under the name Excel-Tech Ltd. (Xltek) is 253 days.
Which FDA product codes appear under Excel-Tech Ltd. (Xltek)?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 2); OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph, 1); OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph, 1).
Next steps
- See all 6 Excel-Tech Ltd. (Xltek) clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Excel-Tech Ltd. (Xltek)'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.