Panels › Anesthesiology › Product code MNS · Class 2
Ventilator, Continuous, Non-Life-Supporting
Regulation 868.5895
3510(k)s in 12 months (47 all time)
1recalls in 12 months (21 all time)
13recalls that name a 510(k)
Top companies in MNS
| Company | 510(k)s | Recalls |
|---|---|---|
| Resmed Corp | 19 | 0 |
| Philips Respironics, Inc. | 1 | 17 |
| Respironics, Inc. | 12 | 2 |
| Respironics Inc., Sleep & Home Respiratory Group | 4 | 0 |
| BMC Medical Co., Ltd. | 1 | 1 |
| Breas Medical AB | 2 | 0 |
| Smd Manufacturing, LLC | 2 | 0 |
| Compal Electronics, Inc. | 1 | 0 |
| Healthdyne Technologies, Inc. | 1 | 0 |
| Innomed Technologies | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 19, 2026 | BMC Medical Co., Ltd. BMC/REACTHEALTH
Luna G3 APAP
REF LG 3600 Open, Classified |
MNS | None listed |
| Jul 2, 2025 | Philips Respironics, Inc. BiPAP A30 Ventilators. Intended to provide noninvasive ventilation support in adult and pediatric patients weighing more than 10 kg.
BiPAP Hybrid A30 Ventilator. Used to provide noninvasive ventilati Open, Classified |
MNS | K113053 |
| Jul 2, 2025 | Philips Respironics, Inc. BiPAP V30 Auto Ventilator. Intended to provide non-invasive ventilatory support for pediatric and adult patients weighing over 10 kg. Open, Classified |
MNS | None listed |
| May 24, 2024 | Philips Respironics, Inc. BiPAP A30 Ventilator, Part Number 1111143 (US and OUS)
OUS Only:
Part Numbers
1111144
1111145
1111147
1111148
1111149
1111150
1111154
1111181
1116155
1111144L
1111144M
1111144V
BR1111143
CN1111143
R1 Open, Classified |
MNS | None listed |
| May 24, 2024 | Philips Respironics, Inc. BiPAP V30 Auto Ventilator, Part Number 1111178 Open, Classified |
MNS | None listed |
| May 23, 2024 | Philips Respironics, Inc. OmniLab Advanced + Ventilator
Product Numbers
1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124 Open, Classified |
MNS | K090539 K113068 +1 |
| Sep 9, 2022 | Philips Respironics, Inc. Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | K090248 |
| Sep 9, 2022 | Philips Respironics, Inc. Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | K090539 |
| Sep 9, 2022 | Philips Respironics, Inc. Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | K090248 |
| Sep 9, 2022 | Philips Respironics, Inc. Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | None listed |
| Sep 9, 2022 | Philips Respironics, Inc. Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | K090248 |
| Sep 9, 2022 | Philips Respironics, Inc. Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency. Open, Classified |
MNS | K113053 |
| Jul 15, 2021 | Philips Respironics, Inc. A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting Open, Classified |
MNS | K113053 K121623 |
| Jul 15, 2021 | Philips Respironics, Inc. A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use Open, Classified |
MNS | K113053 |
| Jul 13, 2021 | Philips Respironics, Inc. DreamStation ASV, DreamStation ST, AVAPS, SystemOne ASV4, C-Series ASV, C-Series S/T and AVAPS, OmniLab Advanced+ Continuous Ventilator, Non-life Supporting
The Philips Respironics E30 ventilator is Open, Classified |
MNS | K090248 K092818 +3 |
| Jul 13, 2021 | Philips Respironics, Inc. Philips Respironics E30 with Humidifier, Continuous Ventilator, Minimum Ventilatory Support, Facility Use; Product Numbers DSX9999H11, INX9999H19, RINX9999H19
The Philips Respironics E30 ventilator Open, Classified |
MNS | None listed |
| Apr 6, 2021 | Philips Respironics, Inc. BiPAP A30, Brazil: Continuous ventilator, non-life-supporting.
Material Number: BR1111143 Terminated |
MNS | None listed |
| Apr 6, 2021 | Philips Respironics, Inc. BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178 Terminated |
MNS | None listed |
| Jul 7, 2009 | Respironics California Inc Respironics BiPAP Focus Noninvasive Ventilator System.
The BiPAP Focus is a non-invasive, pressure support ventilator used to augment the breathing of patients suffering from acute or chronic respira Terminated |
MNS | K053168 |
| Apr 24, 2008 | Respironics, Inc. Non-continuous ventilators under the following brand names: a) Sync S/T Lab, w/o modem US/CAN model number 1010771; b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771; c) Synchrony S w/o mod Terminated |
MNS | K020777 K071509 |
| Apr 24, 2008 | Respironics, Inc. Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories for sleep therapy and ventilation devices, Respironics, Inc., Murrysville, PA 15668. Terminated |
MNS | K020777 K071509 |
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