Infinium Medical, Inc
Largo, FL, US
INFINIUM MEDICAL, INC. appears in FDA device records in Largo, FL. FDA records list 7 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Infinium Medical, Inc between 2010 and 2026. The busiest year on record is 2010, with 2. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 2 |
| 2011 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260438 | Vital Signs Monitor (CLEO2) | MWI | Substantially Equivalent | |
| K142244 | CLEO PATIENT MONITOR | MWI | Substantially Equivalent | |
| K132229 | OMNI PATENT MONITORS | MWI | Substantially Equivalent | |
| K112329 | OMNI PATIENT MONITOR | MWI | Substantially Equivalent | |
| K103737 | OMNI II PATIENT MONITOR | MWI | Substantially Equivalent | |
| K103268 | OMNI EXPRESS | MWI | Substantially Equivalent | |
| K101052 | OMNI III PATIENT MONITOR | MWI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1066427 | 3007513035 | INFINIUM MEDICAL, INC. | 12151 62ND ST., N,, Largo, FL 33773 US | 2026 | and 10 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- BSFAbsorber, Carbon-Dioxide
- FLLContinuous Measurement Thermometer
- KZADevice, Vein Location, Liquid Crystal
- DPSElectrocardiograph
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- BSZGas-Machine, Anesthesia
- FTDLamp, Surgical
- CCWLaryngoscope, Rigid
- OUGMedical Device Data System
- BZQMonitor, Breathing Frequency
- MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- DQAOximeter
- IYNSystem, Imaging, Pulsed Doppler, Ultrasonic
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- DWJSystem, Thermal Regulating
- LGXTable, Examination, Medical, Powered
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1926-2019 | CLEO Patient Monitor /Tranquility VS Patient Monitor | The CLEO & Tranquility VS Patient Monitors 510(k) indications for use in the United States did not include the temperature monitor accessory option. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain