510(k) · Cleared

Cleared

Qwiklead Reusable Electrocardiograph Electrode Patch

K090496510(k) TraditionalCleared Sep 1, 2009188-day reviewClass II21 CFR 870.2360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cardiac Lead Technologies, Inc. · DRX Electrode, Electrocardiograph

Cleared on Sep 1, 2009 as substantially equivalent to K020003 (Bio Protech, Inc., 2002) and 2 other predicates after a 188-day review. Its family tree reaches back 5 generations to 1996.

Decided: Sep 1, 2009
Review: 188 days
Class: Class II
Product code: DRX
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K960968 (1996). 15 ancestors in all, the oldest K930312 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK960968 Medi-Trace 200, Medi-Trace 200-30Graphic Controls Corp. · 1996
4 generations backK023503 Skintact Ecg ElectrodeLeonhard Lang GmbH · 2002
3 generations backK023920 SkintactLeonhard Lang GmbH · 2003
2 generations backK030509 Skintact Ecg Tab ElectrodeLeonhard Lang GmbH · 2003
1 generation backK040784 Protab Ecg Tabb ElectrodeBio Protech, Inc. · 2004
This deviceK090496 Qwiklead Reusable Electrocardiograph Electrode PatchCardiac Lead Technologies, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K960968	Medi-Trace 200, Medi-Trace 200-30	Graphic Controls Corp.	1996	—
−4	K023503	Skintact Ecg Electrode	Leonhard Lang GmbH	2002	—
−3	K023920	Skintact	Leonhard Lang GmbH	2003	—
−2	K030509	Skintact Ecg Tab Electrode	Leonhard Lang GmbH	2003	—
−1	K040784	Protab Ecg Tabb Electrode	Bio Protech, Inc.	2004	—
0 (this device)	K090496	Qwiklead Reusable Electrocardiograph Electrode Patch	Cardiac Lead Technologies, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0
1997	1	0
1999	2	0
2000	2	0
2002	1	0
2004	1	0
2007	1	0

FIG. 1 — Lineage of K090496, 1996–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K020003	Electrocardiograph (Ecg) Electrode, Non-Sterile Summary page 1 …rocardiographic electrode, 21 C.F.R. § 870.2360 Regulatory Class: Class II, Classification Panel 74 Product Code: DRX Predicate Devices: K020003, Telectrode ECG Electrode (Bio Protech Inc.) K073104, Skintact® ECG Electrodes (Leonhard Lang…	Bio Protech, Inc.	2002	—
*	K073104	Skintact and Various Other Tradenames Summary page 1 …s II, Classification Panel 74 Product Code: DRX Predicate Devices: K020003, Telectrode ECG Electrode (Bio Protech Inc.) K073104, Skintact® ECG Electrodes (Leonhard Lang GmbH) K040784, PROTAB ECG Tab Elec…	Leonhard Lang GmbH	2007	—
*	K040784	Protab Ecg Tabb Electrode Summary page 1 …ECG Electrode (Bio Protech Inc.) K073104, Skintact® ECG Electrodes (Leonhard Lang GmbH) K040784, PROTAB ECG Tab Electrode (Bio Protech Inc.) Description of Device: The QwikleadTM Electrocardiograph Electrode Patch…	Bio Protech, Inc.	2004	—

Also cleared against K020003: 1 other device →

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 13 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
1 of the 15 ancestors has a recall of any class.
1 other device also cites its predicate K020003.

How does its category compare?

All DRX devices

DRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · DRX

1in 2017

2007high 7 (2009) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRX

78in 2010

2007high 147 (2007) · low 17 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DRX

6in 2022

2007high 6 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DRX

250in 2025

2007high 250 (2025) · low 15 (2008)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 Qwiklead T M Electrocardiograph Electrode Patch is intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. Such procedures include, in particular, patient ECG surveillance and ECG diagnosis.recording. The Qwiklead T M Electrocardiograph Electrode Patch is intended for single-patient/single application use and is intended to be used on intact (uninjured) skin. The Qwiklead T M Electrocardiograph Electrode Patch is to be used on adults.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090496 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090496: Qwiklead Reusable Electrocardiograph Electrode Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090496

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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