510(k) · Cleared

Cleared

Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20

K053011510(k) TraditionalCleared Dec 14, 200549-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

Bio Protech, Inc. · DRX Electrode, Electrocardiograph

Cleared on Dec 14, 2005 as substantially equivalent to K000206 (Axelgaard Mfg. Co., Ltd., 2000) after a 49-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.

Decided: Dec 14, 2005
Review: 49 days
Class: Class II
Product code: DRX
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000206 (2000). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK000206 Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200Axelgaard Mfg. Co., Ltd. · 2000
This deviceK053011 Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20Bio Protech, Inc. · 2005
Descendant · cites it directly · 0 of its ownK080106 Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008

Most influential descendants

Showing 1 of 1 · See all

K080106Skintact Pre-Wired Ecg Electrodes with Conductive AdhesiveLeonhard Lang GmbH · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000206	Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200	Axelgaard Mfg. Co., Ltd.	2000	—
0 (this device)	K053011	Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20	Bio Protech, Inc.	2005	—
+1	K080106	Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive	Leonhard Lang GmbH	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0

FIG. 1 — Lineage of K053011, 2000–2008Source: 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
*	K000206	Pals Neonatal Pediatric Ecg Electrode, Models PN100, PN200 Summary page 1 …Device Common Name : Neonatal ECG Monitoring Electrode Classification Name: Electrocardiograph Electrode Regulatory Reference : 74 DRX Predicate Device K000206, PAL.S NEONATAL PEDIATRIC ECG ELECTRODE, AXELGAARD MEGa CO., LTD. Description: The PRONEO Neonatal EGG Electr…	Axelgaard Mfg. Co., Ltd.	2000	—

Also cleared against K000206: 3 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K080106	Skintact Pre-Wired Ecg Electrodes with Conductive Adhesive	Leonhard Lang GmbH	2008	0

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, K080106 (Leonhard Lang GmbH, 2008) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K000206.

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?

The PRONEO Neonatal ECG Electrodes are designed for use whenever cardiac monitoring for neonatal or pediatric patients is deemed or desirable by trained medical or emergency personnel. This electrode is for use on neonatal and pediatric patients. The PRONEO Neonatal ECG Electrodes are non-sterile and are to be used on intact (uninjured) skin.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053011 · printed Nov 6, 2026

Cite this page

510(k) Report. “K053011: Pro-Neo Neonatal Ecg Electrode, Models SG15 and SR20.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053011

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