BIPAP A 30 VENTILATORY SUPPORT SYSTEM— 510(k) K113053
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K113053 for BIPAP A 30 VENTILATORY SUPPORT SYSTEM, Substantially Equivalent on 2012-02-01. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Murrysville, PA, US
Recent devices under product code MNS
view allMore clearances from Respironics, Inc.
view allAdverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K113053
K-number listed on FDA's recall record- Z-2036-2025 — 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 ventilation support for the purpose of treating adult and pediatric patients.
- Z-1654-2022 — Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Z-1957-2021 — A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
- Z-1958-2021 — A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
- Z-1973-2021 — 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 intended to provide invasive and non-invasive ventilatory support for individuals with Respiratory Insufficiency. It is specifically for the care of adult and pediatric patients >7 years of age and >18kgs.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113053.
Data sourced from openFDA. This site is unofficial and independent of the FDA.