# K233881: ivWatch® Model 400

- Pathway: 510(k) (Traditional)
- Applicant: Ivwatch, LLC
- Decided: Mar 15, 2024 after 98 days
- Product code: PMS (Peripheral Intravenous (Piv) Infiltration Monitor)
- Device class: 2
- Regulation: 21 CFR 880.5725
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904518 (1990). 13 ancestors in all.
No later device cites it as a predicate yet.
4 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192385: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable, Ivwatch, LLC (2020) Summary page 5.

## Indications for use
The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear and iron sucrose infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for the subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

Source page: https://510kreport.com/device/K233881
Methodology: https://510kreport.com/methodology