Company ยท US
Respironics California, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2012. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
67recalls (0 in 12 months)
63recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 13, 2012 | K110083 | V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE Respironics California, Inc. | CBK |
| Aug 19, 2011 | K110795 | V200 INTELLI-TRAK OPTION Respironics California, Inc. | CBK |
| Dec 22, 2010 | K102054 | V200 VENTILATOR Respironics California, Inc. | CBK |
| Jan 9, 2009 | K082660 | V60 VENTILATOR, MODEL V8000 Respironics California, Inc. | MNT |
| Dec 12, 2007 | K072450 | ESPRIT VENTILATOR AUTO-TRAK SENSITIVITY OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Jul 30, 2007 | K071212 | ESPRIT VENTILATOR SPEAKING MODE OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Jul 8, 2005 | K051262 | ESPRIT VENTILATOR NEONATAL OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Jun 18, 2004 | K041412 | ESPRIT VENTILATOR WITH NICO-ESPRIT INTERFACE OPTION, MODEL V1000 Respironics California, Inc. | CBK |
| Mar 16, 2004 | K034032 | PLV CONTINUUM VENTILATOR, MODEL P2000 Respironics California, Inc. | NOU |
| Nov 20, 2003 | K022750 | PLV CONTINUUM VENTILATOR, MODEL P1000 Respironics California, Inc. | NOU |
| Nov 6, 2002 | K023350 | ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS Respironics California, Inc. | CBK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 18, 2022 | Respironics California, LLC Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States Open, Classified |
MNT | None listed |
| Apr 18, 2022 | Respironics California, LLC Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276) Open, Classified |
MNT | K102985 |
| Apr 18, 2022 | Respironics California, LLC Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, DU1053617, U1053617, R1053618, R1076709) Open, Classified |
MNT | K102985 |
| Feb 25, 2022 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1138747 Open, Classified |
MNT | K102985 |
| Feb 25, 2022 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053617 Open, Classified |
MNT | K102985 |
| Jun 18, 2021 | Respironics California, LLC Philips Respironics V60 Plus Ventilator with Software Versions 3.00 and 3.10.
The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is inten Open, Classified |
MNT | None listed |
| Jun 18, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator with Software Versions 3.00 and 3.10.
The Respironics V60/V60 Plus Ventilator is an assist ventilator and is intended to augment patient breathing. It is intended f Open, Classified |
MNT | None listed |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifier Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 22, 2021 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Open, Classified |
MNT | K082660 |
| Jan 6, 2021 | Respironics California, LLC PHILIPS BATTERY, V60 14.4V, 11.0 Ah, 163 Wh, REF 1076374(1058272), LOT M94663-P1 - Product Usage: The ventilator is intended to be used only with various combinations of Respironics-recommended patien Open, Classified |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V680 Ventilator Part Number 850011 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number U1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number DU1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifier Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1138747 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1137292 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Plus Ventilator Part Number 1137276 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidif Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076717 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076716 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number R1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1076709 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053618 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053617 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053616 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053615 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053614 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Oct 30, 2020 | Respironics California, LLC Philips Respironics V60 Ventilator Part Number 1053613 - Product Usage: intended to be used only with various combinations of Respironics-recommended patient circuits, interfaces (masks), humidifiers, Terminated |
MNT | K082660 |
| Mar 5, 2020 | Respironics California, LLC Philips V60 Ventilators with Power Management PCBA part number 1055906 Open, Classified |
MNT | K082660 |
| Sep 11, 2019 | Respironics California, LLC Respironics V680 Ventilator, Service # 850011, (OUS Only) Open, Classified |
MNT | K082660 |
| Sep 11, 2019 | Respironics California, LLC Respironics RP-Touch Screen, V60/V680 Ventilator Serviced with Touchscreen RP Kit 453561511951 containing a touchscreen labeled as raw part number 1132318 Revision C Open, Classified |
MNT | K082660 |
| Sep 11, 2019 | Respironics California, LLC Respironics RP-UI Assy, V60 Ventilators User Interface RP-Kits, REF/P/N:
453561528931,
453561528941,
453561536451,
453561536461 Open, Classified |
MNT | K082660 |
| Sep 11, 2019 | Respironics California, LLC Respironics V60 Ventilator, Service # 850008, REF: 1053613, 1053614, 1053617, 1053614 Open, Classified |
MNT | K082660 |
| May 18, 2017 | Respironics California Inc Philips V60 Ventilators, Material No. 850008, 1053613, 1053614, 1053615, 1053616, 1053617, 1076715, 1076716, 1076717, DU1053617, U1053617.
Old Material No. 850008, 989805628251, 989805612101, 9898056 Terminated |
MNT | K082660 K102985 |
| Feb 1, 2017 | Respironics California Inc Philips V60 Ventilator with Version 2.20 Software,
Description: V
60 Ventilator,Intl Opt: CFLEX,AVAPS,PPV
V60 Ventilator,Intl Opt: CFLEX,AVAPS
V60 Ventilator,Intl Opt: None
V60 Ventilator,English Op Terminated |
MNT | K102985 |
| Dec 1, 2014 | Respironics California Inc Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator
The Esprit V1000 and Esprit/V200 Conversion Ventilators are microprocessor-controlled, electrically powered mechanical ventilators. Inten Terminated |
CBK | K001208 K023350 +3 |
| Oct 21, 2014 | Respironics California Inc Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits
Microprocessor-controlled, electrically powered mechanical ventilators intended f Terminated |
CBK | K001208 K023350 +2 |
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