510(k) · Cleared
ClearedOri F6T Dry Ecg Monitoring Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orbital Research, Inc. · DRX Electrode, Electrocardiograph
Cleared on Dec 11, 2006 as substantially equivalent to K970796 (3M Healthcare, 1997) and 1 other predicate after an 87-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Dec 11, 2006
- Review
- 87 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K863116 (1986). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK863116 Cardiofax Ecg-6551 (Electrocardiogrph)Nihon Kohden America, Inc. · 1986
- 2 generations backK982470 Ecg Electrodes ApronTapuz Medical Technology, Ltd. · 1998
- 1 generation backK043361 Accuheart Electrode BeltAdvanced Bioelectric Corporation · 2005
- This deviceK062760 Ori F6T Dry Ecg Monitoring ElectrodeOrbital Research, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K863116 | Cardiofax Ecg-6551 (Electrocardiogrph) | Nihon Kohden America, Inc. | 1986 | — |
| −2 | K982470 | Ecg Electrodes Apron | Tapuz Medical Technology, Ltd. | 1998 | — |
| −1 | K043361 | Accuheart Electrode Belt | Advanced Bioelectric Corporation | 2005 | — |
| 0 (this device) | K062760 | Ori F6T Dry Ecg Monitoring Electrode | Orbital Research, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 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 |
|---|---|---|---|
| * | K970796 | 3M Red Dot 2560 & 2570 Monitoring ElectrodesSummary page 1…antially equivalent to the following legally marketed ECG electrodes: -3M Red DotTM 2570 Monitoring Electrode (K970796) 3M Health Care -AccuHeartTM Electrode Belt (K043361) Advanced Bi… | 1997 |
| * | K043361 | Accuheart Electrode BeltSummary page 1…-3M Red DotTM 2570 Monitoring Electrode (K970796) 3M Health Care -AccuHeartTM Electrode Belt (K043361) Advanced Bioelectric Corporation Substantial Equivalence The F6T Electrode is substantially… | 2005 |
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?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- 1 of the 7 ancestors has a recall of any class.
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 ORI F6T Dry ECG Monitoring Electrodes are intended for use in adults (persons 18 years and older) in all ECG monitoring applications where standard ECG monitoring electrodes are used. The F6T Electrodes can be used in short term and long term (up to 2 days) ECG monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062760 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062760: Ori F6T Dry Ecg 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/K062760
Report an extraction error
Are you the manufacturer?
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