BIPAP A 40 VENTILATORY SUPPORT SYSTEM— 510(k) K121623
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K121623 for BIPAP A 40 VENTILATORY SUPPORT SYSTEM, Substantially Equivalent on 2012-12-14. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code MNT
- 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 MNT
view allMore clearances from Respironics, Inc.
view allAdverse events under product code MNT
product code MNT- Death
- 118
- Injury
- 324
- Malfunction
- 25,451
- Other
- 2
- Total
- 25,895
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 K121623
K-number listed on FDA's recall record- Z-2037-2025 — BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric patients. BiPAP A40 Pro - sold OUS
- Z-1817-2024 — OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124
- Z-1958-2021 — A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K121623.
Data sourced from openFDA. This site is unofficial and independent of the FDA.