Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Excel Tech. , Ltd. — Predicate Candidate Screening
58 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
235 days90th percentile
58clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062549 | XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 1052 | Excel Tech. , Ltd. | 2006-10-04 | 35 | 0 |
| K061269 | XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES | Excel Tech. , Ltd. | 2006-08-14 | 101 | 0 |
| K053386 | XLTEK EMU40 EEG HEADBOX, MODEL PK1072 | Excel Tech. , Ltd. | 2006-04-21 | 137 | 0 |
| K053058 | XLTEK NEUROPATH, MODEL PK1070 | Excel Tech. , Ltd. | 2006-02-07 | 99 | 0 |
| K052112 | XLTEK XCALIBUR EMG / LT, MODEL PK1P33, PK1059 | Excel Tech. , Ltd. | 2005-10-28 | 85 | 0 |
| K052111 | XLTEK CLEAR SIGNAL SUB-DERMAL NEEDLE, MODELS 102889, 102798, | Excel Tech. , Ltd. | 2005-08-17 | 13 | 0 |
| K042223 | XLTEK CONNEX IP HEADBOX, MODEL 1054 | Excel Tech. , Ltd. | 2004-09-16 | 30 | 0 |
| K042150 | XLTEK TREX MODEL#10309 | Excel Tech. , Ltd. | 2004-08-27 | 18 | 0 |
| K040358 | XLTEK PROTEKTOR STIMULATOR, MODELS 10247 & 10248 | Excel Tech. , Ltd. | 2004-08-06 | 175 | 1 |
| K040360 | EMU128S, MODEL EX-NW-128S | Excel Tech. , Ltd. | 2004-03-12 | 28 | 0 |
| K022037 | XLTEK SLEEP SYSTEM | Excel Tech. , Ltd. | 2002-09-10 | 78 | 0 |
| K021599 | 96 CHANNEL EEG HEADBOX MODEL EMU96 | Excel Tech. , Ltd. | 2002-08-13 | 90 | 0 |
| K011794 | XLTEK LED GOGGLES, MODEL LED-01 | Excel Tech. , Ltd. | 2001-10-01 | 115 | 0 |
| K010086 | REAL PATIENT EXCEL NEUROWORK, MODEL EX-RP-EEG (PROPOSED) | Excel Tech. , Ltd. | 2001-04-09 | 88 | 0 |
| K010092 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL REAL PATIENT EP-8-RP ( | Excel Tech. , Ltd. | 2001-04-02 | 81 | 0 |
| K010088 | REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-03-26 | 74 | 0 |
| K010089 | REAL PATIENT WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS- | Excel Tech. , Ltd. | 2001-03-26 | 74 | 0 |
| K010090 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4-RP (PROPOSED) | Excel Tech. , Ltd. | 2001-03-26 | 74 | 0 |
| K010087 | XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP | Excel Tech. , Ltd. | 2001-03-19 | 67 | 0 |
| K010084 | REAL PATIENT REAL PATIENT 128 CHANNEL EEG HEADBOX, MODEL EX- | Excel Tech. , Ltd. | 2001-03-16 | 64 | 0 |
| K010085 | EEG REAL PATIENT SPIKE AND EVENT DETECTOR MODULE, MODEL EX-S | Excel Tech. , Ltd. | 2001-03-15 | 63 | 0 |
| K010150 | 64 CHANNEL EEG / MODEL NUMBER EX-NW-64 | Excel Tech. , Ltd. | 2001-02-09 | 23 | 0 |
| K010091 | EEG WITH VIDEO, MODEL EX-NW | Excel Tech. , Ltd. | 2001-02-01 | 21 | 0 |
| K002332 | EEG SPIKE AND EVENT DETECTOR MODULE | Excel Tech. , Ltd. | 2000-10-06 | 66 | 0 |
| K000919 | 128 CHANNEL EEG HEADBOX, MODEL EX-NW-128 | Excel Tech. , Ltd. | 2000-08-31 | 162 | 0 |
| K001166 | ULTRA V THERAPEUTIC ULTRASOUND | Excel Tech. , Ltd. | 2000-07-07 | 88 | 0 |
| K001103 | WIRELESS AMBULATORY EEG, MODEL EX-AMB-WIRELESS (PROPOSED) | Excel Tech. , Ltd. | 2000-06-30 | 86 | 0 |
| K001101 | XLTEK EVOKED POTENTIAL HEADBOX, MODEL EP-4 | Excel Tech. , Ltd. | 2000-06-30 | 86 | 0 |
| K000898 | EEG WITH VIDEO, MODEL EX-NW | Excel Tech. , Ltd. | 2000-04-14 | 24 | 0 |
| K992313 | XL TEK EVOKED POTENTIAL HEADBOX, MODEL EP-16 | Excel Tech. , Ltd. | 1999-08-19 | 41 | 0 |
| K991903 | EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1) | Excel Tech. , Ltd. | 1999-08-04 | 61 | 0 |
| K991900 | XLTEK POLYSOMNOGRAPHY HEADBOX, MODEL # PSG-40 | Excel Tech. , Ltd. | 1999-07-12 | 38 | 0 |
| K982479 | EXCEL AMBULATORY EEG | Excel Tech. , Ltd. | 1998-10-14 | 90 | 0 |
| K980214 | EXCEL NEURO WORKS | Excel Tech. , Ltd. | 1998-04-21 | 90 | 0 |
| K972157 | EXCEL AV STIM 1000 | Excel Tech. , Ltd. | 1998-01-30 | 235 | 0 |
| K960096 | ULTRA III | Excel Tech. , Ltd. | 1996-03-27 | 76 | 0 |
| K960489 | ULTRA IV | Excel Tech. , Ltd. | 1996-03-27 | 54 | 0 |
| K955860 | MULTI III, IV | Excel Tech. , Ltd. | 1996-03-22 | 86 | 0 |
| K955387 | ISOTRON III, ISOTRON IV | Excel Tech. , Ltd. | 1996-03-22 | 121 | 0 |
| K941144 | EXCEL EMG | Excel Tech. , Ltd. | 1995-11-07 | 607 | 0 |
| K941815 | ISOTRON III | Excel Tech. , Ltd. | 1995-05-03 | 386 | 0 |
| K940200 | EXCEL TX | Excel Tech. , Ltd. | 1994-06-07 | 145 | 0 |
| K932730 | EXCEL'S EST-30 HO:YAG LASER SYSTEM | Excel Tech. , Ltd. | 1994-03-01 | 267 | 0 |
| K931051 | MODEL 110 ND:YAG LASER | Excel Tech. , Ltd. | 1993-06-25 | 116 | 0 |
| K921952 | ULTRA III | Excel Tech. , Ltd. | 1993-03-09 | 316 | 0 |
| K923076 | ULTRA SX | Excel Tech. , Ltd. | 1993-03-09 | 257 | 0 |
| K924729 | EXCEL TRIPULSE MODEL3000 | Excel Tech. , Ltd. | 1993-01-15 | 116 | 0 |
| K921954 | ISOTRON III | Excel Tech. , Ltd. | 1992-08-26 | 121 | 0 |
| K921953 | MULTI III | Excel Tech. , Ltd. | 1992-08-26 | 121 | 0 |
| K922375 | EXCEL DUOPULSE MODEL 3000 COMBINATION HO/ER:YAG | Excel Tech. , Ltd. | 1992-07-08 | 49 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda