Data / Medical devices / United States / Smisson-Cartledge Biomedical LLC
Smisson-Cartledge Biomedical LLC: FDA-registered device maker in Macon, GA, United States, 2 510(k) clearances
Smisson-Cartledge Biomedical LLC is registered with the FDA (registration 3006158088) in Macon, GA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 12, 2022. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3006158088
- Address
- 487 Cherry Street Third Street Tower, Macon, GA, United States, 31201
- Owner or operator
- SMISSON-CARTLEDGE BIOMEDICAL LLC (9097032)
- Roles
- Specification developer
- First device listed
- February 6, 2007
- Registered through
- 2026
- Brand names listed
- SMISSON-CARTLEDGE TIS-1200, TIS-1200 Thermal Infusion System, ThermaCor 1200, ThermaCor 1200 Disposable Sets
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Pump, Infusion | FRN | 2 | Specification developer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Specification developer | accessdata.fda.gov |
| Warmer, Thermal, Infusion Fluid | LGZ | 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 12, 2022 | K202461 | ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System | LGZ | Substantially Equivalent | Smisson-Cartledge Biomedical, LLC | accessdata.fda.gov |
| October 26, 2006 | K052055 | SMISSON-CARTLEDGE THERMAL INFUSION SYSTEM, MODEL TIS-1200 | LGZ | Substantially Equivalent | Smisson-Cartledge Biomedical, LLC | 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 18, 2021 | 86808 | Class I | Terminated | ThermaCor 1200 Disposable Sets Components of the Smisson-Cartledge Biomedical ThermaCor 1200 Rapid Thermal Infusion System, used for infusion of: -crystalloid, colloid, or blood product, including packed red blood cells, | Customers are being notified of results from a Toxicological Risk Assessment related to potential for aluminum ions to leach into warmed fluids. | accessdata.fda.gov |
Compare with other makers
- All makers of Warmer, Thermal, Infusion Fluid
- All makers of Pump, Infusion
- All makers of Set, Administration, Intravascular
Updated August 12, 2022. 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.