K222212 is an FDA 510(k) clearance for the ivWatch Model 400. 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 August 24, 2022, 30 days after receiving the submission on July 25, 2022.
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 | K222212 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 25, 2022 |
| Decision Date | August 24, 2022 |
| Days to Decision | 30 days |
| Submission Type | Special |
| 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. |