510(k) · Cleared
ClearedTomey DTL Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tomey Corporation USA · HLZ Electrode, Corneal
Cleared on May 9, 1997 as substantially equivalent to K844409 (Sauquoit Industries, Inc., 1985) and 2 other predicates after a 364-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- May 9, 1997
- Review
- 364 days
- Class
- Class II
- Product code
- HLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K820254 (1982). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK820254 Gold Foil Erg ElectrodesCadwell Laboratories, Inc. · 1982
- This deviceK961805 Tomey DTL ElectrodeTomey Corporation USA · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K820254 | Gold Foil Erg Electrodes | Cadwell Laboratories, Inc. | 1982 | — |
| 0 (this device) | K961805 | Tomey DTL Electrode | Tomey Corporation USA | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 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 HLZ? 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 HLZ device
- #1 K253586 RM Electrode (RMH 25-01)score 11.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K844409 | DTL ElectrodeSummary page 1…The Tomey DTL Electrode is substantially equivalent in design and function to the DTL Electrode as manufactured by Sauquoit Industries, Inc., Scranton, PA (as cleared in K844409), the Gold Foil ERG Electrodes as manufactured by Cadwell Laboratories, Inc., Kennewick, WA (as cleared in K820254), and the ERG-… | 1985 |
| * | K820254 | Gold Foil Erg ElectrodesSummary page 1…Sauquoit Industries, Inc., Scranton, PA (as cleared in K844409), the Gold Foil ERG Electrodes as manufactured by Cadwell Laboratories, Inc., Kennewick, WA (as cleared in K820254), and the ERG-JET Electrode as manufactured by Life Tech, Houston, TX (as cleared in K823767). The Tomey DTL Electrode is also… | 1982 |
| * | K823767 | Erg-Jet ElectrodeSummary page 1…as manufactured by Cadwell Laboratories, Inc., Kennewick, WA (as cleared in K820254), and the ERG-JET Electrode as manufactured by Life Tech, Houston, TX (as cleared in K823767). The Tomey DTL Electrode is also similar to the ERG electrode that was included with the Tomey PE-400/PS-400 Portable ERG syste… | 1983 |
| † | K932571 | Tomey PE-400 Portable Erg & Vep with Optional PS-4 | 1995 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All HLZ devicesHLZ Electrode, Corneal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HLZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HLZ
Too few HLZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HLZ
No recall names HLZ since 2007.
Adverse event reports per year · HLZ
No MAUDE report names HLZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Tomey DTL Electrode is intended for use in the measurement and recording of ERG signals from the ocular surfaces of the eye. These measurements are only to be performed by licensed practitioners and trained technicians within a medical environment.
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/K961805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961805: Tomey DTL Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961805
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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