510(k) · Cleared
Recalled · Class II · 2019Model 1700, Hydro Prep
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Physiometrix, Inc. · GYB Media, Electroconductive
Cleared on May 14, 1997 after a 78-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it. It has been recalled 3 times.
- Decided
- May 14, 1997
- Review
- 78 days
- Class
- Class II
- Product code
- GYB
- Recalls
- 3
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK970694 Model 1700, Hydro PrepPhysiometrix, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK212787 GT5 conductive & abrasive gelWuhan Greentek Pty, Ltd. · 2021
Most influential descendants
Showing 1 of 1 · See all- K212787GT5 conductive & abrasive gelWuhan Greentek Pty, Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970694 | Model 1700, Hydro Prep | Physiometrix, Inc. | 1997 | — |
| +1 | K212787 | GT5 conductive & abrasive gel | Wuhan Greentek Pty, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GYB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GYB device
- #1 K243749 Jmoon Conductive Gelscore 10.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212787 | GT5 conductive & abrasive gel | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2019 | Class II | Z-0675-2020 | Process control | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia |
| Oct 29, 2019 | Class II | Z-0704-2020 | Process control | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
| Oct 29, 2019 | Class II | Z-0705-2020 | Process control | Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K212787 (Wuhan Greentek Pty, Ltd., 2021) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GYB devicesGYB Media, Electroconductive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GYB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GYB
101in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GYB
1in 2021
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GYB
2in 2025
MAUDE reports naming product code GYB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 9 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 1 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 3 |
| 2020 | 3 | 198 | 0 | 2 |
| 2021 | 2 | — | 1 (1) | 4 |
| 2022 | 3 | 101 | 0 | 4 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970694: Model 1700, Hydro Prep.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970694
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026