Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) · Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
56 daysmedian FDA review time
171 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242930 | Natus BrainWatch System | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-11-19 | 56 | 0 |
| K233649 | ALGO Pro Newborn Hearing Screener (ALGO Pro) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2024-03-08 | 115 | 0 |
| K203500 | RetCam Envision | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2021-04-13 | 134 | 0 |
| K200878 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2020-05-18 | 46 | 0 |
| K173936 | Natus Photic Stimulator | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 | 171 | 0 |
| K180290 | Natus Brain Monitor Amplifier | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-14 | 133 | 1 |
| K180421 | Natus NeuroWorks | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-14 | 26 | 0 |
| K173690 | Grass TWin | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-03-09 | 98 | 0 |
| K180181 | Natus Quantum | Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek) | 2018-02-22 | 30 | 0 |
| K172711 | Comet-PLUS | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2017-11-03 | 56 | 0 |
| K163163 | XLTEK EMU40EX EEG Headbox | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-12-14 | 34 | 0 |
| K162595 | Trex_HD | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-11-04 | 50 | 0 |
| K152301 | Background Pattern Classification [BPc(TM)] | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2016-06-03 | 294 | 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