Excel Tech. , Ltd.: FDA clearances and approvals
Excel Tech. , Ltd. has 58 FDA 510(k) clearances (first 1985, latest 2006), across 17 product codes in 4 review panels. Median 510(k) review time: 88 days.
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 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 Excel Tech. , Ltd. have?
Excel Tech. , Ltd. has 58 FDA 510(k) clearances (first 1985, latest 2006), across 17 product codes in 4 review panels.
How long does FDA take to clear Excel Tech. , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Excel Tech. , Ltd.'s cleared 510(k)s is 88 days.
What devices does Excel Tech. , Ltd. make?
Its most frequent FDA product codes are GWQ (Full-Montage Standard Electroencephalograph, 15); GEX (Powered Laser Surgical Instrument, 7); GWF (Stimulator, Electrical, Evoked Response, 6).
Has Excel Tech. , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Excel Tech. , Ltd. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.