Excel Tech. , Ltd.: FDA filings under this applicant name
FDA lists 58 510(k) clearances under the applicant name “Excel Tech. , Ltd.” (first 1985, latest 2006), across 17 product codes in 4 review panels. Median 510(k) review time under this name: 88 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 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 | 15 | 15 |
| GEX | Powered Laser Surgical Instrument | 7 | 7 |
| GWF | Stimulator, Electrical, Evoked Response | 6 | 6 |
| IPF | Stimulator, Muscle, Powered | 6 | 6 |
| LIH | Interferential Current Therapy | 5 | 5 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 3 | 3 |
| OMB | Automatic Event Detection Software For Full-Montage Electroencephalograph | 3 | 3 |
| GWE | Stimulator, Photic, Evoked Response | 2 | 2 |
| IKN | Electromyograph, Diagnostic | 2 | 2 |
| OLV | Standard Polysomnograph With Electroencephalograph | 2 | 2 |
Plus 7 more product codes.
Review panels
Most recent Excel Tech. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 | ETN | 2006-10-04 | 35 |
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | GXY | 2006-08-14 | 101 |
| K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | GWQ | 2006-04-21 | 137 |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | JXE | 2006-02-07 | 99 |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | IKN | 2005-10-28 | 85 |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, 102799, 102382 | GXZ | 2005-08-17 | 13 |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | OMB | 2004-09-16 | 30 |
| K042150 | XLTEK TREX MODEL#10309 | GWQ | 2004-08-27 | 18 |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | GWF | 2004-08-06 | 175 |
| K040360 | EMU128S, MODEL EX-NW-128S | GWQ | 2004-03-12 | 28 |
48 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Excel Tech. , Ltd..
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 Scientific, Inc. (8 510(k)s)
- Excel-Tech Ltd. (Xltek) (6 510(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.?
FDA lists 58 510(k) clearances under the applicant name “Excel Tech. , Ltd.” (first 1985, latest 2006), across 17 product codes in 4 review panels. 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.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Excel Tech. , Ltd. is 88 days.
Which FDA product codes appear under Excel Tech. , Ltd.?
The most frequent FDA product codes under this applicant name are GWQ (Full-Montage Standard Electroencephalograph, 15); GEX (Powered Laser Surgical Instrument, 7); GWF (Stimulator, Electrical, Evoked Response, 6).
Next steps
- See all 58 Excel Tech. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GWQ, Excel Tech. , Ltd.'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.