# K153605: ivWatch Model 400

- Pathway: 510(k) (Special)
- Applicant: Ivwatch, LLC
- Decided: Feb 11, 2016 after 56 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: 6 generations back to K904518 (1990). 10 ancestors in all.
4 later devices descend from it; 1 cites it directly.
4 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142374: ivWatch Model 400, Ivwatch, LLC (2015) Summary page 4.

## Most influential descendants
- K162478: ivWatch (2016), 3 descendants of its own
- K192385: ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable (2020), 1 descendant of its own
- K233881: ivWatch® Model 400 (2024), 0 descendants of its own
- K222212: ivWatch Model 400 (2022), 0 descendants of its own

## 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, uncolored infusates, as an adjunctive device to the clinical evaluation in the hospital setting of patients 18 years old or greater with peripherally-inserted IVs (PIVs) on the forearm or dorsal aspect of the hand. The device is indicated to assess patients for 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 physicians, or under the direction of a physician, who have been trained in the use of the ivWatch Model 400.

Source page: https://510kreport.com/device/K153605
Methodology: https://510kreport.com/methodology