Data / Medical devices / United States / Neuralynx, Inc.
Neuralynx, Inc.: FDA-registered device maker in Bozeman, MT, United States, 2 510(k) clearances
Neuralynx, Inc. is registered with the FDA (registration 3009391672) in Bozeman, MT, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 14, 2025. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3009391672
- Address
- 105 Commercial Dr, Bozeman, MT, United States, 59715
- Owner or operator
- Neuralynx, Inc. (10038712)
- Roles
- Manufacturer
- First device listed
- November 4, 2011
- Registered through
- 2027
- Brand names listed
- ASHB FIBER OPTIC DUPLEX CONN 2m, ASHB FIBER OPTIC DUPLEX CONN 7m, ATLAS Neurophysiology System, ATLAS Stim Headbox (NK), ATLAS Stim Headbox Software, Atlas Headbox Expansion Panel, Atlas Headbox Interface Cable (HD), Atlas Headbox Interface Cable (NK) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cortical | GYC | 2 | Manufacturer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 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 |
|---|---|---|---|---|---|---|
| April 14, 2025 | K250094 | Atlas Stim Headbox (NK) (31-0601-0077); Atlas Stim Headbox (Touchproof) (31-0601-0089); Atlas Stim Headbox (HD) (31-0601-0132); ASHB FIBER OPTIC DUPLEX CONN 2m (31-0204-0001); ASHB FIBER OPTIC DUPLEX CONN 7m (31-0204-0002); ATLAS Stim Headbox Software (36-0301-0006); Atlas Headbox Interface Cable (NK) (31-0204-003); Atlas Headbox Interface Cable (Touchproof) (31-0204-004); Atlas Headbox Interface Cable (HD) (31-0204-005); Atlas Headbox Expansion Panel (31-0607-0014) | GYC | Substantially Equivalent | Neuralynx, Inc. | accessdata.fda.gov |
| June 30, 2011 | K110967 | ENTERPRISE ELECTROPHYSIOLOGY SYSTEM | OMC | Substantially Equivalent | Neuralynx, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 14, 2022 | 89843 | Class II | Ongoing | ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies und | Atlas Stim Headbox (ASHB) was delivered to US customers under a premise that the device had an Investigational Device Exemption (IDE) and was for research use only, but the manufacturer does not have an approved IDE by the FDA. The product has not undergone electrical safety testing and has not received regulatory clearance. | accessdata.fda.gov |
Compare with other makers
Updated April 14, 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.