510(k) K254289
K254289 is an FDA 510(k) premarket notification submitted by Oxytek Medical Technology Co., Ltd. for the device "Portable Oxygen Concentrator (OX-1A-E, OX-1B)". The FDA issued a decision of Substantially Equivalent on Sep 23, 2026. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Oxytek Medical Technology Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 23, 2026
- Date Received
- Dec 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Generator, Oxygen, Portable
- Device Class
- Class II
- Regulation Number
- 868.5440
- Review Panel
- AN
- Submission Type
- 510(k)