510(k) · Cleared
ClearedCenterridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg Electrodes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Team Innovations, Inc. · DRX Electrode, Electrocardiograph
Cleared on Jul 22, 2010 as substantially equivalent to K932454 (3M Health Care, Ltd., 1993) and 1 other predicate after a 45-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Jul 22, 2010
- Review
- 45 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K932454 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK932454 3M Red Dot 2330 Resting Ekg Electrode3M Health Care, Ltd. · 1993
- This deviceK101576 Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg…Team Innovations, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932454 | 3M Red Dot 2330 Resting Ekg Electrode | 3M Health Care, Ltd. | 1993 | — |
| 0 (this device) | K101576 | Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg Electrodes | Team Innovations, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 DRX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K932454 | 3M Red Dot 2330 Resting Ekg ElectrodeSummary page 1…lly equivalent to several predicate legally marketed devices: * 3M Health Care, Red Dot Resting EKG Electrode, catalog number 2330 covered by 5 10O(K) number K932454, and * Bin-Detek, Inc., Trace Rite Solid Gel EGG Electrodes, part numbers DE1O70, LT3Ol SG(PSG), LT4OI SG(PSG) and LT… | 1993 |
| * | K964213 | Trace Rite Solid Gel Ecg ElectrodesSummary page 1…* Bin-Detek, Inc., Trace Rite Solid Gel EGG Electrodes, part numbers DE1O70, LT3Ol SG(PSG), LT4OI SG(PSG) and LT601SG(PSG), covered by 510O(K) number K(964213. The CenterRidge ECG Electrodes are non-traditional tab electrodes, capable of diagnostic or monitoring use, depending on materi… | 1996 |
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 2 ancestors has a recall.
- 1 other device also cites its predicate K932454.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DRX
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · DRX
78in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRX
6in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRX
250in 2025
MAUDE reports naming product code DRX, 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 | 3 | 147 | 0 | 47 |
| 2008 | 3 | 17 | 0 | 15 |
| 2009 | 7 | 89 | 0 | 36 |
| 2010 | 5 | 78 | 4 | 48 |
| 2011 | 0 | — | 0 | 80 |
| 2012 | 0 | — | 0 | 41 |
| 2013 | 1 | — | 0 | 70 |
| 2014 | 1 | — | 0 | 27 |
| 2015 | 0 | — | 1 | 58 |
| 2016 | 0 | — | 0 | 37 |
| 2017 | 1 | — | 0 | 55 |
| 2018 | 0 | — | 0 | 43 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 0 | — | 5 | 53 |
| 2021 | 0 | — | 1 | 55 |
| 2022 | 0 | — | 6 | 61 |
| 2023 | 0 | — | 0 | 113 |
| 2024 | 0 | — | 0 | 61 |
| 2025 | 0 | — | 0 | 250 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECO use (CenterRidge Diagnostic ECO Electrode) and one for monitoring ECG use (CenterRidge Monitorig-ECG Electrode). The CenterRidge Diagnostic ECQ Electrode is a diagnostic, single use (single patient). disposable ECO electrode. This electrode is intended to acquire ECG signals from the surface of the body, The intended poptiation is adults…
Read the full statement (131 words)
The subject devices are ECG surface electrodes and will be manufactured in two configurations: one for diagnostic ECO use (CenterRidge Diagnostic ECO Electrode) and one for monitoring ECG use (CenterRidge Monitorig-ECG Electrode).
The CenterRidge Diagnostic ECQ Electrode is a diagnostic, single use (single patient). disposable ECO electrode. This electrode is intended to acquire ECG signals from the surface of the body, The intended poptiation is adults and pediatrics. The intended duration of body contact is less than 24 hours.
The CenterRidgt Monitoring ECG Electrode is a monitoring, single use (single patient), disposable ECO electrode. This electrode is intended to acquire ECO signals from the surface of the body. The intended population is adults and pediatrics. The intended duration of body contact is greater than 24 hours but less than 30 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101576 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101576: Centerridge Diagnostic Ecg Electrode, Centerridge Monitoring Ecg Electrodes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101576
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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