Data / Medical devices / South Korea / Hydrochem Co., Ltd
Hydrochem Co., Ltd: FDA-registered device maker in Gangeung-Si Gangwon, South Korea, 6 510(k) clearances
Hydrochem Co., Ltd is registered with the FDA (registration 3045816954) in Gangeung-Si Gangwon, South Korea. It lists 7 device types. The FDA files 6 510(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
- 3045816954
- Address
- 202-14, Gwahakdonji-Ro Sacheon-Myeon Building B, 1st & 2nd Floor, Gangeung-Si Gangwon, South Korea, 25441
- Owner or operator
- Hydrochem Co., Ltd (10095897)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- May 18, 2026
- Registered through
- 2026
- Brand names listed
- Dressing Wound Bed Sore w/ SOP, Face Mask Surgical w/ SOP, Techno Web, Face Mask Surgical, Antimicrobial w/ SOP, HC Portable Oxygen Concentrator w/ SOP, Mask, Oxygen, Fresh Patch w/ SOP, O2 Respirator, Surgical w/ SOP, Travel Socks, Antimicrobial
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Contract manufacturer | accessdata.fda.gov |
| Respirator, N95, For Use By The General Public In Public Health Medical Emergencies | NZJ | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) | DWL | 2 | Manufacturer | accessdata.fda.gov |
| Surgical Mask With Antimicrobial/Antiviral Agent | OUK | 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 |
| December 20, 2012 | K123085 | FUTURO (TM) TRAVEL KNEE-HIGHS; FUTURO (TM) TRAVEL SOCKS; FUTURO (TM) TRAVEL STOCKINGS; FUTURO (TM) TRAVEL PANTYHOSE | DWL | Substantially Equivalent | 3M Company | accessdata.fda.gov |
| May 26, 2011 | K101128 | BIOFRIEND BIOMASK SURGICAL FACEMASK, MODELS UNIVERSAL BF-200-2001 AND PREMIUM BF-200-3013 | OUK | Substantially Equivalent | Filligent Limited | accessdata.fda.gov |
| May 8, 2007 | DEN060009 | 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE; 3M N95 HOME RESPIRATOR | NZJ | Unknown | 3M Company | accessdata.fda.gov |
| August 23, 1995 | K952945 | AQUAFLO HYDROGEL WOUND DRESSING & PACKER | NAE | Substantially Equivalent for Some Indications | Sherwood Medical Co. | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, N95, For Use By The General Public In Public Health Medical Emergencies
- All makers of Dressing, Wound, Hydrogel Without Drug And/Or Biologic
- All makers of Mask, Surgical
- All makers of Respirator, Surgical
- All makers of Surgical Mask With Antimicrobial/Antiviral Agent
- 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.