REMSTAR AUTO A-FLEX HT— 510(k) K113068
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K113068 for REMSTAR AUTO A-FLEX HT, Substantially Equivalent on 2011-12-16. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code BZD
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Murrysville, PA, US
Recent devices under product code BZD
view allMore clearances from Respironics, Inc.
view allAdverse events under product code BZD
product code BZD- Death
- 4,440
- Injury
- 53,099
- Malfunction
- 213,222
- Other
- 17
- Total
- 270,778
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 K113068
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-1974-2021 — SystemOne (Q-Series), DreamStation, DreamStation Go, Dorma 400, Dorma 500, REMstar SE Auto Noncontinuous Ventilators 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 K113068.
Data sourced from openFDA. This site is unofficial and independent of the FDA.