# K970694: Model 1700, Hydro Prep

- Pathway: 510(k) (Traditional)
- Applicant: Physiometrix, Inc.
- Decided: May 14, 1997 after 78 days
- Product code: GYB (Media, Electroconductive)
- Device class: 2
- Regulation: 21 CFR 882.1275
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K085306: NuPrep. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K212787: GT5 conductive & abrasive gel (2021), 0 descendants of its own

## Recalls of this device
- Nov 7, 2019 · Class II · Z-0675-2020: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia
- Oct 29, 2019 · Class II · Z-0704-2020: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
- Oct 29, 2019 · Class II · Z-0705-2020: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

## Indications for use
HydroPrep.and NuPrep are skin preparation materials that are designed for use by EEG Technicians. Both substances are applied to the skin surface with a cotton swab in order to reduce skin impedance and increase signal quality recorded with EEG electrodes. HydroPrep is not intended for use with stimulating electrodes.

Source page: https://510kreport.com/device/K970694
Methodology: https://510kreport.com/methodology