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.
Clearance details
- Applicant
- Honsun (Nantong) Co., Ltd.
- Product code
- 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.