510(k) · Cleared
ClearedCambridge Heart HI-Res Ecg Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cambridge Heart, Inc. · DRX Electrode, Electrocardiograph
Cleared on Aug 29, 1996 as substantially equivalent to K791006 (Electronics For Medicine, Inc., 1979) and 3 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1979. 2 later devices descend from it.
- Decided
- Aug 29, 1996
- Review
- 90 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K782079 (1979). 4 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK782079 Electrode System, Quik-PrepQuinton, Inc. · 1979
- This deviceK962115 Cambridge Heart HI-Res Ecg ElectrodeCambridge Heart, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK013615 Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK090249 Modification to: Micro-Induction 1000 SystemHarbinger Medical, Inc. · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K782079 | Electrode System, Quik-Prep | Quinton, Inc. | 1979 | — |
| 0 (this device) | K962115 | Cambridge Heart HI-Res Ecg Electrode | Cambridge Heart, Inc. | 1996 | — |
| +1 | K013615 | Micro-Induction 1000 System | Harbinger Medical, Inc. | 2002 | — |
| +2 | K090249 | Modification to: Micro-Induction 1000 System | Harbinger Medical, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1989 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 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? (4)
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 |
|---|---|---|---|
| * | K791006 | Smart BilectrodesSummary page 1…ridge Heart Hi-Res™ ECG Electrode Common/Usual Name of Device: ECG Electrode Device CIassificatién: Electrocardiograph Electrode Predicate Devices: Smart™ Bi-Lectrode (K791006) Quinton Quik-Prep Electrode(K782079) 3M Red Dot Electrode (K821438) HP M1176A Cardiac Monitor (K8826089) 600010 === Page 2 ==… | 1979 |
| * | K782079 | Electrode System, Quik-PrepSummary page 1…mon/Usual Name of Device: ECG Electrode Device CIassificatién: Electrocardiograph Electrode Predicate Devices: Smart™ Bi-Lectrode (K791006) Quinton Quik-Prep Electrode(K782079) 3M Red Dot Electrode (K821438) HP M1176A Cardiac Monitor (K8826089) 600010 8-27-1996 &:00PM FROM CAMBRIDGE HEA… | 1979 |
| * | K821438 | Red Dot Monitoring Electrodes #2260/65Summary page 1…ectrode Device CIassificatién: Electrocardiograph Electrode Predicate Devices: Smart™ Bi-Lectrode (K791006) Quinton Quik-Prep Electrode(K782079) 3M Red Dot Electrode (K821438) HP M1176A Cardiac Monitor (K8826089) 600010 8-27-1996 &:00PM FROM CAMBRIDGE HEART 617 271 9488 2.2 Device Desc… | 1982 |
| * | K882609 | Models M1175A & M1176A Component Monitoring SystemSummary page 4…tional single segment electrode. 000012 8-27-1996 8:01PM FROM CAMBRIDGE HEART B17 271 9488 P.8 The CH 2000 Stress Test System and the HP M1176A device, K882609, measure respiratory impedance in a similar manner. Both devices inject a low level high-frequency current through the torso, usi… | 1989 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013615 | Micro-Induction 1000 System | 2002 | 1 |
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 4 ancestors has a recall.
- Of its descendants, K013615 (Harbinger Medical, Inc., 2002) has gone furthest, with 1 descendant of its own.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Cambridge Heart Hi-Res™ ECG Electrode is intended for short term use to measure electrocardiogram signals at rest and during ECG stress testing with the CH 2000 Stress Test System and successor systems. This device is supplied non-sterile and is intended for one time 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/K962115 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962115: Cambridge Heart HI-Res Ecg Electrode.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962115
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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