Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Excel-Tech Ltd. (Xltek) — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
287 daysmedian FDA review time
804 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K131266 | TREZ_HD | Excel-Tech Ltd. (Xltek) | 2014-02-14 | 287 | 0 |
| K123079 | OLYMPIC BRAINZ MONITOR | Excel-Tech Ltd. (Xltek) | 2013-05-08 | 219 | 2 |
| K120260 | ICTA | Excel-Tech Ltd. (Xltek) | 2012-06-29 | 154 | 0 |
| K090277 | NATUS SLEEPWORKS, MODEL 104017 | Excel-Tech Ltd. (Xltek) | 2011-04-19 | 804 | 0 |
| K100126 | STELLATE GRIDVIEW | Excel-Tech Ltd. (Xltek) | 2010-12-03 | 318 | 0 |
| K081741 | NEUROLINK IP, MODEL PK1113 | Excel-Tech Ltd. (Xltek) | 2008-10-31 | 134 | 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