Thermedx LLC
Solon, OH, US
THERMEDX, LLC appears in FDA device records in Solon, OH. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Thermedx LLC between 2010 and 2021. The busiest year on record is 2010, with 1. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K210628 | X-FLO Fluid Management System | HIG | Substantially Equivalent | |
| K172048 | FluidSmart | HIG | Substantially Equivalent | |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | HIG | Substantially Equivalent | |
| K102275 | THERMEDX 37-5 ELECTROCAUTERY PROBES, MODELS MPJ200, MPJ210, MPS220, MPN230, BPH240 | GEI | Substantially Equivalent | |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P2000 | HIG | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007495879 | 3007495879 | THERMEDX, LLC | 31200 Solon Road, Solon, OH 44139 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1463-2015 | Fluid Management System P4000; for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic procedures. | To correct software bugs that could affect the ability to accurately measure fluid deficit. | Class II | Terminated | |
| Z-2555-2014 | The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevention of peri-operative hypothermia. The fluid is warmed via an internal infrared mechanism. Additionally the system will hold suction canisters for the collection of used irrigant. | A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain