# K222671: DeltaScan Patch

- Pathway: 510(k) (Traditional)
- Applicant: Prolira B.V.
- Decided: Feb 2, 2023 after 149 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: 3 generations back to K002734 (2000). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143506: Bis Standard Sensor,1-Channel (3 Electrodes); Bis Pedi Sensor,1-Channel,3 Electrodes; Bis Quatro Sensor; Bis Pedi-XP Sensor,2-Channel (4 Electrodes); Bis Extend Sensor; Bis Bilateral Sensor,4-Channel (6 Elecrodes); Bis Insight Sensor,Cvi-Enabled,2-Channel (4 Electrodes), Covidien (2015) Summary page 4.

## Indications for use
The DeltaScan Patch is applied directly to the patient’s skin to record EEG signals. The DeltaScan Patch is dedicated and only intended to be used in combination with the DeltaScan Monitor (K222680) through a proprietary connector design. Please refer to the Instructions for Use and the Instructions for Use on the Primary packaging of the DeltaScan Patch for more information.

Source page: https://510kreport.com/device/K222671
Methodology: https://510kreport.com/methodology