Data / Medical devices / United States / Shikani Medical LLC
Shikani Medical LLC: FDA-registered device maker in Lutherville, MD, United States, 1 510(k) clearance
Shikani Medical LLC is registered with the FDA (registration 3008278458) in Lutherville, MD, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 25, 2010. 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
- 3008278458
- Address
- 1629 York Road, Lutherville, MD, United States, 21093
- Owner or operator
- Shikani Medical LLC (d/b/a The Airway Company) (10031493)
- Roles
- Repackager or relabeler, Specification developer
- First device listed
- June 30, 2010
- Registered through
- 2026
- Brand names listed
- HME for use with Shikani Speaking valves, SSV2 speaking valve, Shikani speaking valves, oxygen tubing
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Specification developer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 2 | Specification developer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| June 25, 2010 | K100995 | SHIKANI SPEAKING VALVE | JOH | Substantially Equivalent | Shikani Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tubing, Pressure And Accessories
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Condenser, Heat And Moisture (Artificial Nose)
Updated June 25, 2010. 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.