510(k) Report

Devices descending from K012633

5 later devices reach Respironics Heated Humidifier through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K031176Invacare Polaris EX Heated Humidifier, Model ISP4000Invacare Corp.20040—
+1K030090H2 Heated HumidifierRespironics, Inc.20033—
+2K042184Goodknight H20, Model M-114600-00Mallinckrodt Developpement France20052—
+3K080439Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…Mallinckrodt Developpement France20081—
+4K082237Puritan Bennett, Sandman Duo and Sandman Duo STMallinckrodt Developpement France20080—