ClearanceBrief
510(k) K052110 ยท BZD Ventilator, Non-Continuous (Respirator)

M-SERIES PRO CPAP SYTEM

ApplicantRespironics, Inc., Murrysville PA, US
DecisionSubstantially Equivalent, Oct 20, 2005
ReceivedAug 4, 2005
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K052110

DateFirm and productCodeLinked 510(k)
Apr 24, 2008Respironics, Inc.
Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1 model number 1039618; b) filter reusable PLV 2/pkg model number 35220; c) LX UL Fine Filter 2 pack model number 1006193;
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Power Cord Accessory under the following brand names a) Power Cord W/C7 End Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model number 1005894. Filter, mask, and/or accessories
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Non-continuous ventilators accessories under the following brand names: a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS and b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA51
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) REMStar (Tower) Ultrafine Qty 1 model number 1036915, b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS; c) REM
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) REMStar M US model number DS100 and b) REMStar M w/Humid US model number DS100H. Filter, mask, and/or accessories for sleep
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) REMStar Plus M US model number DS200; b) REMStar Plus M w/Humid AHP model number AHP200H; c) REMStar Plus M w/Humid US model n
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) REMStar Pro2 Domestic model number 1020923; b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS; c) REMStar Pro M w/
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
RP M Series Pollen Filter Kit 1 pack model number 1035443. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Power Supply under the following brand names: a) RP, Power Supply Assembly model number H3600-015, and b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask, and/or accessories for
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
Non-continuous ventilator accessories under the following brand names: a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185; b) RP-BIPAP M Series Keypad model number 1038122; and c) RP-BIPAP Pro 2 /P
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-REM Power Cord N. AMER model number 362524. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironic
Terminated
BZDNone listed
Apr 24, 2008Respironics, Inc.
RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668.
Terminated
BZDNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.