FDA applicant
Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
FDA records 13 decisions for Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) (Oakville, CA) from 2016 to 2024: 13 510(k) clearances. Most are in product codes GWQ (Full-Montage Standard Electroencephalograph) and OLV (Standard Polysomnograph With…). Since 2016 its 510(k)s took a median of 56 days from receipt to decision, against 108 for FDA’s reviews in the same codes and years. Its devices cite 18 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Natus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2025
Class I Class II/III not classified
Planning a device like Natus Medical Incorporated Dba…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Natus”
FDA records each applicant name separately; these may or may not be the same firm.