510(k) · Cleared
ClearedTextronics Ecg Electrode
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Textronics, Inc. · DRX Electrode, Electrocardiograph
Cleared on Nov 2, 2007 as substantially equivalent to K944497 (Msb, Ltd., 1996) and 2 other predicates after a 147-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- Nov 2, 2007
- Review
- 147 days
- Class
- Class II
- Product code
- DRX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K863116 (1986). 8 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 deviceK071576 Textronics Ecg ElectrodeTextronics, Inc. · 2007
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) | K071576 | Textronics Ecg Electrode | Textronics, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K944497 | Unilect, Monitab and Biotrace-HRSummary page 2…16 CJ F Predicate Devices Unomedical 4560M Unilect Short Term EGG Electrodes (K944497) Medi-Trace model 530 EGG Conductive Adhesive Electrodes (K945479) AccuheartTm Electrode belt (K043361) Intended Use… | 1996 |
| * | K945479 | Medi-Trace (R) 500 Ecg ElectrodeSummary page 2…F Predicate Devices Unomedical 4560M Unilect Short Term EGG Electrodes (K944497) Medi-Trace model 530 EGG Conductive Adhesive Electrodes (K945479) AccuheartTm Electrode belt (K043361) Intended Use I Indications for Use The TextroniCSTm EGG Electrode is intended… | 1995 |
| * | K043361 | Accuheart Electrode BeltSummary page 2…Unomedical 4560M Unilect Short Term EGG Electrodes (K944497) Medi-Trace model 530 EGG Conductive Adhesive Electrodes (K945479) AccuheartTm Electrode belt (K043361) Intended Use I Indications for Use The TextroniCSTm EGG Electrode is intended for use in general electrocardiograp… | 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 21 years and passes through 4 companies; a new generation was cleared every 6.4 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K944497.
How does its category compare?
All DRX devicesDRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 TextronicsTM ECG Electrode is intended for use in general electrocardiograph monitoring and recording procedures.
The TextronicsTM ECG Electrode is indicated for use with most ECG instruments on the market. It is indicated applications including resting ECGs, exercise ECGs, and/or ambulatory monitoring.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071576 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071576: Textronics 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/K071576
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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