BIPAP AUTOSV ADVANCED— 510(k) K090539
Substantially EquivalentRespironics Inc., Sleep & Home Respiratory Group
FDA 510(k) clearance K090539 for BIPAP AUTOSV ADVANCED, Substantially Equivalent on 2009-10-30. 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
- Traditional
- 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 K090539
K-number listed on FDA's recall record- Z-1817-2024 — OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
- Z-1658-2022 — Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090539.
Data sourced from openFDA. This site is unofficial and independent of the FDA.