510(k) · Cleared
ClearedHmicro Wired C-Patch Electrode, Trade Name Subject to Change
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hmicro, Inc. · DRX Electrode, Electrocardiograph
Cleared on Jul 24, 2014 as substantially equivalent to K000690 (Minnesota Mining and Mfg. Co., 2000) after a 191-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Jul 24, 2014
- Review
- 191 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000690 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000690 3M Red Dot Radiolucent Monitoring Electrode with Conductive AdhesiveMinnesota Mining and Mfg. Co. · 2000
- This deviceK140096 Hmicro Wired C-Patch Electrode, Trade Name Subject to ChangeHmicro, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000690 | 3M Red Dot Radiolucent Monitoring Electrode with Conductive Adhesive | Minnesota Mining and Mfg. Co. | 2000 | — |
| 0 (this device) | K140096 | Hmicro Wired C-Patch Electrode, Trade Name Subject to Change | Hmicro, Inc. | 2014 | — |
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? (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 |
|---|---|---|---|
| * | K000690 | 3M Red Dot Radiolucent Monitoring Electrode with Conductive AdhesiveSummary page 1…ardiograph electrodes (21 CFR 870.2360, pro code DRX) Class: 2 Panel Identification: Cardiovascular Predicate device: 3M Red Dot ECG electrodes (K000690, SE 5.17.2000) Device description: The HMicro Wired C-Patch Electrode is a single 3-inch patch electrode designed to be placed on… | 2000 |
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 no recall.
- 1 other device also cites its predicate K000690.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 HMicro, Inc. Wired C-Patch is indicated for ECG monitoring of adults at rest when the upper
left chest or center chest is available to place the patch.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140096: Hmicro Wired C-Patch Electrode, Trade Name Subject to Change.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140096
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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