Panels › Anesthesiology › Product code MNT · Class 2
Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Regulation 868.5895
1510(k)s in 12 months (25 all time)
0recalls in 12 months (64 all time)
54recalls that name a 510(k)
Top companies in MNT
| Company | 510(k)s | Recalls |
|---|---|---|
| Respironics California, Inc. | 1 | 52 |
| Philips Respironics, Inc. | 0 | 7 |
| Respironics, Inc. | 6 | 1 |
| Breas Medical AB | 4 | 0 |
| Fisher & Paykel Healthcare Limited | 3 | 0 |
| Resmed Germany, Inc. | 3 | 0 |
| Puritan Bennett Corp. | 1 | 1 |
| Resmed, Ltd. | 1 | 1 |
| Bio-Med Devices, Inc. | 0 | 1 |
| DRE Medical Group Inc | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 2, 2025 | Philips Respironics, Inc. BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients.
BiPAP A40 Pro - sold OUS Open, Classified |
MNT | K121623 |
| May 24, 2024 | Philips Respironics, Inc. BiPAP A40 Ventilators:
BiPAP A40, Part Numbers 1111169 (US and OUS)
and
(OUS ONLY)1111170
1111171
1111173
1111174
1111175
1111177
1116156
1111170S
BR1111169
CN1111169
IT1111169
R1111169
R1111177
R11 Open, Classified |
MNT | None listed |
| Sep 28, 2023 | Philips Respironics, Inc. Philips Respironics V60/V60 Plus Ventilator,
PCBA Part Number: 453561544461
V60 Device Part Numbers 1053617 (US) and 1137276 (Philippines) Open, Classified |
MNT | K102985 |
| Jun 29, 2023 | DRE Medical Group Inc Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Model Number: R1053618 and R107 Open, Classified |
MNT | None listed |
| 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 |
| Apr 6, 2021 | Philips Respironics, Inc. BiPAP A40, Brazil: Continuous ventilator, non-life-supporting.
Material Number: BR1111169 Terminated |
MNT | None listed |
| Apr 6, 2021 | Philips Respironics, Inc. BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting.
Material Number: 1111177 Terminated |
MNT | None listed |
| Apr 6, 2021 | Philips Respironics, Inc. BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting.
Material Number: R1111177 Terminated |
MNT | None listed |
| Apr 6, 2021 | Philips Respironics, Inc. BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169 Terminated |
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 |
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