Data / Medical devices / United States / Fte Dynamics, LLC
Fte Dynamics, LLC: FDA-registered device maker in Chino Hills, CA, United States, 1 510(k) clearance
Fte Dynamics, LLC is registered with the FDA (registration 3012762174) in Chino Hills, CA, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 23, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3012762174
- Address
- 13215 Sonrisa Dr, Chino Hills, CA, United States, 91709
- Owner or operator
- FTE Dynamics, LLC (10095054)
- Roles
- Specification developer
- First device listed
- January 19, 2026
- Registered through
- 2026
- Brand names listed
- BIGEASY Mask, BIGEASY Valve, EFM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | 1 | Specification developer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Specification developer | accessdata.fda.gov |
| Valve, Non-Rebreathing | CBP | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 23, 2015 | K142402 | BigEasy Non-Rebreathing Valve | CBP | Substantially Equivalent | 12th Man Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Valve, Non-Rebreathing
- All makers of Mask, Gas, Anesthetic
- All makers of Flowmeter, Tube, Thorpe, Back-Pressure Compensated
Updated March 23, 2015. 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.