Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K242930Natus BrainWatch SystemNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2024-11-19560
K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2024-03-081150
K203500RetCam EnvisionNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2021-04-131340
K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2020-05-18460
K173936Natus Photic StimulatorNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-06-151710
K180290Natus Brain Monitor AmplifierNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-06-141331
K180421Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-14260
K173690Grass TWinNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2018-03-09980
K180181Natus QuantumNatus Medical Incorporated Dba Excel_Tech Ltd. (Xltek)2018-02-22300
K172711Comet-PLUSNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2017-11-03560
K163163XLTEK EMU40EX EEG HeadboxNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-12-14340
K162595Trex_HDNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-11-04500
K152301Background Pattern Classification [BPc(TM)]Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2016-06-032940

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