510(k) · Cleared
ClearedTaylor General Purpose Monitoring Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Taylor Industries, Inc. · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 30, 1996 as substantially equivalent to K900519 (Classic Medical Products, Inc., 1990) after a 213-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- May 30, 1996
- Review
- 213 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K900519 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK900519 Classic Ecg/Stimulating NO. 1700 SeriesClassic Medical Products, Inc. · 1990 · Recalled
- This deviceK954951 Taylor General Purpose Monitoring ElectrodeTaylor Industries, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K900519 | Classic Ecg/Stimulating NO. 1700 Series | Classic Medical Products, Inc. | 1990 | 1 |
| 0 (this device) | K954951 | Taylor General Purpose Monitoring Electrode | Taylor Industries, Inc. | 1996 | — |
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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K900519 | Classic Ecg/Stimulating NO. 1700 SeriesSummary page 1…S Electrode is substantially equivalent, with similar indications for use to the foliowing devices which are currently legally marketed and in commercial distribution: *K900519 Classic Medical Products Classic ECG/ Stimulating No. 1700 Series Electrode Device Description The Tayior TENS Electrode is int… | 1990 |
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K900519.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Taylor TENS electrode is designed to be used in monitoring/ stimulating applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient’s skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance imbalance, which can cause the pickup of 60 cycle noise, known as baseline hum. This means that the…
Read the full statement (122 words)
The Taylor TENS electrode is designed to be used in monitoring/ stimulating applications. This type of application places the emphasis on the patient's comfort. We recommend that the patient’s skin be clean, dry, and shaved, if necessary. It has been shown that a mild abrasion with a prep pad or with fine sandpaper will reduce the inter electrode impedance imbalance, which can cause the pickup of 60 cycle noise, known as baseline hum. This means that the way a patient's skin is prepared for the electrode, will affect the quality of how the users ECG tracings come out and the performance during stimulation procedures.
The Taylor TENS electrode is for Health Care Professionals only. It is intended for single patient use only.
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/K954951 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954951: Taylor General Purpose Monitoring Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954951
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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