Data / Medical devices / South Korea / Kbbio Co., Ltd.
Kbbio Co., Ltd.: FDA-registered device maker in Seongnam Gyeonggi, South Korea, 3 510(k) clearances
Kbbio Co., Ltd. is registered with the FDA (registration 3017608802) in Seongnam Gyeonggi, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 22, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3017608802
- Address
- 165 Sunhwan-ro, Jungwon-gu, Seongnam Gyeonggi, South Korea, 13207
- Owner or operator
- KBBIO Co., Ltd. (10078362)
- Roles
- Manufacturer
- First device listed
- June 15, 2026
- Registered through
- 2026
- Brand names listed
- HC Portable Oxygen Concentrator w/ SOP, O2 Respirator, Surgical w/ SOP, Vaginal Hydrogel Packing System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Vaginal Hydrogel Packing System | QXR | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2025 | K251764 | Oxygen Concentrator-P2-O5E | CAW | Substantially Equivalent | Qingdao Kingon Medical Science and Technology Co., Ltd. | accessdata.fda.gov |
| January 12, 2024 | K233022 | Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small | MSH | Substantially Equivalent | Owens & Minor (O&M) Halyard, Inc. | accessdata.fda.gov |
| August 22, 2023 | DEN220052 | BrachyGel Vaginal Hydrogel Packing System | QXR | Unknown | Brachyfoam, Inc. D/B/A Advaray | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, Surgical
- All makers of Vaginal Hydrogel Packing System
- All makers of Generator, Oxygen, Portable
Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.