OxyGo Portable Oxygen Concentrator (1400-7000)— 510(k) K252407
Substantially EquivalentMv Life, LLC
FDA 510(k) clearance K252407 for OxyGo Portable Oxygen Concentrator (1400-7000), Substantially Equivalent on 2026-04-23. Applicant: Mv Life, LLC. Device class: 2.
Summary
Mv Life's OxyGo Portable Oxygen Concentrator (1400-7000) is filed under product code CAW (Generator, Oxygen, Portable).
Class II, 21 CFR 868.5440. Anesthesiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Mv Life filed from Orlando, Florida. The record shows 266 calendar days from receipt to decision (July 31, 2025 to April 23, 2026).
Clearance details
- Applicant
- Mv Life, LLC
- Product code
- Product code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orlando, FL, US
Recent devices under product code CAW
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.