Data / Medical devices / United States / Tenacore LLC
Tenacore LLC: FDA-registered device maker in Costa Mesa, CA, United States, 1 510(k) clearance
Tenacore LLC is registered with the FDA (registration 3008403701) in Costa Mesa, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 18, 2005. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008403701
- Address
- 3115 Airway Ave, Costa Mesa, CA, United States, 92626
- Owner or operator
- Tenacore LLC (10080555)
- Roles
- Specification developer
- First device listed
- February 9, 2021
- Registered through
- 2026
- Brand names listed
- Tenacore Transducers For Fetal Ultrasonic And Tokodynamometer Monitoring
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Monitoring, Perinatal | HGM | 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 |
|---|---|---|---|---|---|---|
| August 18, 2005 | K043075 | TENACORE TRANSDUCERS FOR FETAL ULTRASONIC AND TOKODYNAMOMETER MONITORING | HGM | Substantially Equivalent | Tenacore Holdings, 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 |
|---|---|---|---|---|---|---|
| February 25, 2021 | 87470 | Class I | Terminated | Alaris Infusion Pump Module, Model 8100, serviced/repaired by Tenacor with an impacted bezel repair part | Bezel repair parts used, not by the original manufacturer, to service and repair infusion pump modules, may over time experience cracking or separation of the posts from the bezel. The separation of one or more bezel repair part posts may result in free flow, over infusion, under infusion or interruption of infusion. | accessdata.fda.gov |
Compare with other makers
Updated April 2, 2021. 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.