Infinium Medical, Inc
FDA Regulatory Profile
Infinium Medical, Inc appears in FDA public data with 1 recall, 7 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1926-2019, Class II) was initiated on May 31, 2019. Its most recent 510(k) clearance was granted on August 14, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 7
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1926-2019 | Class II | CLEO Patient Monitor /Tranquility VS Patient Monitor | May 31, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K260438 | Vital Signs Monitor (CLEO2) | August 14, 2026 |
| K142244 | CLEO PATIENT MONITOR | February 6, 2015 |
| K132229 | OMNI PATENT MONITORS | February 21, 2014 |
| K112329 | OMNI PATIENT MONITOR | September 8, 2011 |
| K103737 | OMNI II PATIENT MONITOR | June 2, 2011 |
| K103268 | OMNI EXPRESS | November 23, 2010 |
| K101052 | OMNI III PATIENT MONITOR | August 11, 2010 |