510(k) K113053 ยท MNS Ventilator, Continuous, Non-Life-Supporting
BIPAP A 30 VENTILATORY SUPPORT SYSTEM
| Applicant | Respironics, Inc., Murrysville PA, US |
| Decision | Substantially Equivalent, Feb 1, 2012 |
| Received | Oct 13, 2011 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K113053
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Jul 15, 2021 | Philips Respironics, Inc. A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting Open, Classified |
MNS | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.