BIPAP AUTOSV— 510(k) K090248
Substantially EquivalentRespironics Inc., Sleep & Home Respiratory Group
FDA 510(k) clearance K090248 for BIPAP AUTOSV, Substantially Equivalent on 2009-03-04. Applicant: Respironics Inc., Sleep & Home Respiratory Group. Device class: 2.
Clearance details
- Applicant
- Respironics Inc., Sleep & Home Respiratory Group
- 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
- Special
- Location
- Murrysville, PA, US
Recent devices under product code MNS
view allMore clearances from Respironics Inc., Sleep & Home Respiratory Group
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 K090248
K-number listed on FDA's recall record- Z-1655-2022 — Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Z-1657-2022 — Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
- Z-1659-2022 — 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.
- 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 K090248.
Data sourced from openFDA. This site is unofficial and independent of the FDA.