Data / Medical devices / United States / 3B Medical Inc
3B Medical Inc: FDA-registered device maker in W Jefferson, OH, United States, 17 510(k) clearances
3B Medical Inc is registered with the FDA (registration 3042507287) in W Jefferson, OH, United States. It lists 5 device types. The FDA files 17 510(k) clearances under its listings, the newest dated September 29, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3042507287
- Address
- 1054 Gateway Park Dr, W Jefferson, OH, United States, 43162
- Owner or operator
- React Health (10040143)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- April 22, 2020
- Registered through
- 2026
- Brand names listed
- F2 Single-Patient Vented Full Face Mask (BMC-FM2) - (Device Modification) ((BMC-NM Nasal Mask, BMC-NM2 Nasal Mask, G3 B25VT, G3 B30VT, G3X APAP, Generator, oxygen, portable, HomeFill® Oxygen System, Luna G3 APAP, Luna G3 BPAP 25/30VT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | 2 | Repackager or relabeler | accessdata.fda.gov |
| Ventilator, Continuous, Non-Life-Supporting | MNS | 2 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 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 |
|---|---|---|---|---|---|---|
| September 29, 2025 | K243833 | Portable oxygen concentrator (JAY-1000P) | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
| December 8, 2022 | K213210 | Oxygen Concentrator, Model JAY-5AW | CAW | Substantially Equivalent | Longfian Scitech Co., Ltd. | accessdata.fda.gov |
| December 5, 2022 | K213169 | BPAP System | MNS | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| March 25, 2022 | K212263 | Luna G3 BPAP System | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| March 9, 2022 | K211155 | Auto CPAP System | BZD | Substantially Equivalent | BMC Medical Co., Ltd. | accessdata.fda.gov |
| August 6, 2020 | K200890 | Invacare Perfecto2V Oxygen Concentrator | CAW | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| August 29, 2019 | K191159 | Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity | CAW | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| June 1, 2018 | K172234 | Oxygen Concentrator | CAW | Substantially Equivalent | Sysmed (China) Co., Ltd. | accessdata.fda.gov |
| September 5, 2017 | K163464 | Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2) | BZD | Substantially Equivalent | Bmc Medical., Ltd. | accessdata.fda.gov |
| September 27, 2016 | K160630 | Invacare Platinum Mobile Oxygen Concentrator | CAW | Substantially Equivalent | Invacare Corporation | accessdata.fda.gov |
| September 8, 2016 | K153387 | Luna CPAP and Auto CPAP System | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| December 23, 2013 | K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | BZD | Substantially Equivalent | 3B Medical, Inc. | accessdata.fda.gov |
| February 16, 2012 | K112271 | 3B WILLOW | BZD | Substantially Equivalent | 3B Products, LLC | accessdata.fda.gov |
| July 7, 2003 | K020332 | RESPIRATORY HUMIDIFIER, MODEL MR850 | BTT | Substantially Equivalent | Fisher & Paykel Healthcare, Ltd. | accessdata.fda.gov |
| July 23, 2002 | K021685 | VENTURE HOMEFILL II WITH OXYGEN CONSERVER | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| July 2, 2002 | K020386 | INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02 | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
| September 15, 1992 | K914488 | MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS | CAW | Substantially Equivalent | Invacare Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Nasal, Oxygen
- All makers of Generator, Oxygen, Portable
- All makers of Humidifier, Respiratory Gas, (Direct Patient Interface)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Ventilator, Continuous, Non-Life-Supporting
Updated September 29, 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.