510(k) Report

Devices descending from K936039

24 later devices reach Algo-2 Newborn Hearing Screener through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K013137Algo 3 Newborn Hearing ScreenerNatus Medical, Inc.200151
+1K012384Ear MuffinsBio-Logic Systems Corp.20010—
+1K993177SABRESle Limited199916—
+2K111555Circumaural Adhesive ReplacementR & D Medical Products, Inc.20110—
+2K073665Algo 5 Newborn Hearing ScreenerNatus Medical, Inc.20081—
+2K030823Algo 3I Newborn Hearing ScreenerNatus Medical, Inc.200311
+2K013977Echo-Screen T, TA, TD, Tda, TCFischer-Zoth Audiologic Systems, Inc.200214—
+2K011842Sabre CompacSle Limited20020—
+3K233649ALGO Pro Newborn Hearing Screener (ALGO Pro)Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)20240—
+3K211147ALGO 7iPath Medical GmbH20210—
+3K141446Echo-Screen Iii Pro Hearing Screener with Barcode Scanner, Echo-Screen Iii Pro Hearing…Natus Medical Incorporated20140—
+3K132957Madsen Accuscreen Type 1077Gn Otometrics20143—
+3K131141EarprobePath Medical GmbH20130—
+3K122067Type 1077 AccuscreenGn Otometrics20129—
+3K100661EarprobePath Medical GmbH201001
+3K061744Cochlea-Scan / Cochlea-Scan PlusBio-Logic Systems Corp.20065—
+4K143395Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck…Otodynamics, Ltd.20152—
+4K133012SentieroPath Medical GmbH201444
+5K234095OtoNova/OtoNova ProOtodynamics20240—
+5K240430Otoport ProOtodynamics, Ltd.20240—
+5K220139QScreenPath Medical GmbH20220—
+5K213345Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONEPath Medical GmbH202204
+5K171038Hearing Healthcare ProDb Diagnostic Systems, Inc.20171—
+6K183201Hearing Healthcare ProDb Diagnostic Systems, Inc.20190—