# K243788: IceCap product line

- Pathway: 510(k) (Traditional)
- Applicant: Bioserenity Medical Devices Group
- Decided: Mar 13, 2025 after 94 days
- Product code: GXY (Electrode, Cutaneous)
- Device class: 2
- Regulation: 21 CFR 882.1320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K830295 (1983). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151576: Neon EEG, Incereb, Ltd. (2015) Summary page 5.
- K223644: Neuronaute with IceCap 2 & IceCap 2 Small, Bioserenity (2023) Summary page 5.

## Indications for use
The IceCaps are medical devices used as EEG electrodes. They are used by Healthcare Professionals on a patient in case of neurological disorders with a short or long-term EEG record (up to 72 hours). IceCap 2 shall be placed on patients weighing at least 10 kg (22.05 Ibs) and having a head circumference above 43 cm (16.93 inches). IceCap Neonate shall be placed on the head of babies, newborns and premature babies.

Source page: https://510kreport.com/device/K243788
Methodology: https://510kreport.com/methodology