K192385 is an FDA 510(k) clearance for the ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable. This device is classified as a Peripheral Intravenous (piv) Infiltration Monitor (Class II - Special Controls, product code PMS).
Submitted by Ivwatch, LLC (Newport News, US). The FDA issued a Cleared decision on July 2, 2020, 303 days after receiving the submission on September 3, 2019.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5725. Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations..
| 510(k) Number | K192385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2019 |
| Decision Date | July 02, 2020 |
| Days to Decision | 303 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | PMS - Peripheral Intravenous (piv) Infiltration Monitor |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5725 |
| Definition | Peripheral Catheter Monitor (piv) Indicated For The Detection Of Subcutaneous Infiltrations And Extravasations. |