510(k) · Cleared

Cleared

Accu-Lead

K050443510(k) TraditionalCleared Sep 2, 2005192-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

Kentec Medical, Inc. · DRX Electrode, Electrocardiograph

Cleared on Sep 2, 2005 as substantially equivalent to K011564 (Neotech Products, Inc., 2002) after a 192-day review. Its family tree reaches back 1 generation to 2002. 27 later devices descend from it.

Decided: Sep 2, 2005
Review: 192 days
Class: Class II
Product code: DRX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011564 (2002). 27 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011564 NeoleadNeotech Products, Inc. · 2002
This deviceK050443 Accu-LeadKentec Medical, Inc. · 2005
Descendant · cites it directly · 26 of its ownK092744 Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009
Descendant · 2 generations on · 24 of its ownK132694 Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014
Descendant · 3 generations on · 23 of its ownK141968 Nuvasive NVM5 SystemNuvasive, Inc. · 2014
Descendant · 4 generations on · 22 of its ownK143641 NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · Recalled
Descendant · 5 generations on · 13 of its ownK152942 NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2009high 4 (2023) · low 0 (2010)2026

Most influential descendants

Showing 5 of 27 · See all

K092744Neonatal Ecg Electrode, M203KENR & D Medical Products, Inc. · 2009 · cites it directly26descendants
K132694Nuvasive NVM5 SystemNu Vasive, Incorporated · 2014 · 2 generations on24descendants
K141968Nuvasive NVM5 SystemNuvasive, Inc. · 2014 · 3 generations on23descendants
K143641NuVasive NVM5 SystemNu Vasive, Incorporated · 2015 · 4 generations on22descendants
K152942NuVasiveNVM5 SystemNu Vasive, Incorporated · 2016 · 5 generations on13descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011564	Neolead	Neotech Products, Inc.	2002	—
0 (this device)	K050443	Accu-Lead	Kentec Medical, Inc.	2005	—
+1	K092744	Neonatal Ecg Electrode, M203KEN	R & D Medical Products, Inc.	2009	—
+2	K132694	Nuvasive NVM5 System	Nu Vasive, Incorporated	2014	—
+3	K141968	Nuvasive NVM5 System	Nuvasive, Inc.	2014	—
+4	K143641	NuVasive NVM5 System	Nu Vasive, Incorporated	2015	1
+5	K152942	NuVasiveNVM5 System	Nu Vasive, Incorporated	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2011	1	0
2014	2	0
2015	1	0
2016	1	0
2017	3	0
2018	3	0
2019	1	0
2021	2	0
2022	2	0
2023	4	0
2024	1	0
2025	2	0
2026	3	0

FIG. 1 — Lineage of K050443, 2002–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K011564	Neolead Summary page 1 …PERFORMANCE DATA COMPARISON NONCLINICAL TEST 510(k) Number Proprietary Name Manufacturer NON-CLINICAL TEST K011564 Neolead Neotech Products ANSI/AAMI ECI2-…	Neotech Products, Inc.	2002	—

Also cleared against K011564: 3 other devices →

What descends from it? (27)

See all 27

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K092744	Neonatal Ecg Electrode, M203KEN	R & D Medical Products, Inc.	2009	26

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.
Of its descendants, K092744 (R & D Medical Products, Inc., 2009) has gone furthest, with 26 descendants of its own.
3 other devices also cite its predicate K011564.

How does its category compare?

All DRX devices

DRX Electrode, Electrocardiograph: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

Single Use Only - Disposable

The NEONATAL PEDIATRIC ECG ELECRODE is intended for use whenever cardiac monitoring of neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on the surface of the body.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050443 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050443: Accu-Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050443

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