Portable Oxygen Concentrator— 510(k) K252399
Substantially EquivalentHonsun (Nantong) Co., Ltd.
FDA 510(k) clearance K252399 for Portable Oxygen Concentrator, Substantially Equivalent on 2026-06-17. Applicant: Honsun (Nantong) Co., Ltd.. Device class: 2.
Summary
The Portable Oxygen Concentrator from Honsun (Nantong) is filed under CAW, portable oxygen generators. The name is generic, and the record gives no model numbers.
Class II, 21 CFR 868.5440. Anesthesiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Honsun filed from Nantong, China. Review took 321 calendar days (July 31, 2025 to June 17, 2026).
Clearance details
- Applicant
- Honsun (Nantong) Co., Ltd.
- 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
- Nantong, CN
Recent devices under product code CAW
view allMore clearances from Honsun (Nantong) Co., Ltd.
view all- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
- K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
- K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)
- K211629 — Infrared forehead thermometer LD-FT-100B
- K192500 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer
Adverse 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.