510(k) · Cleared

Cleared

Opus S Model 4121 and 4124 Pacemakers

K970072510(k) TraditionalCleared Aug 29, 1997233-day reviewClass III21 CFR 870.3610

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

Ela Medical, Inc. · DXY Implantable Pacemaker Pulse-Generator

Cleared on Aug 29, 1997 as substantially equivalent to K900461 (Ela Medical, Inc., 1990) and 3 other predicates after a 233-day review. Its family tree reaches back 1 generation to 1988.

Decided: Aug 29, 1997
Review: 233 days
Class: Class III
Product code: DXY
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K882391 (1988). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK882391 Opus 3 Pulse Generators Models 4003,4004,4023,4024Ela Medical, Inc. · 1988
This deviceK970072 Opus S Model 4121 and 4124 PacemakersEla Medical, Inc. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K882391	Opus 3 Pulse Generators Models 4003,4004,4023,4024	Ela Medical, Inc.	1988	—
0 (this device)	K970072	Opus S Model 4121 and 4124 Pacemakers	Ela Medical, Inc.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1995	2	0

FIG. 1 — Lineage of K970072, 1988–1997Source: 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 DXY? 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? (4)

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
*	K900461	Opus Model 4021, Vvi, 5MM Unipolar Summary page 1 …Person: Catherine G. Goble 510(k) Number: K970072 Date of Judgment of Substantial Equivalence Sent to Applicant: Predicate Devices: ELA Medical Opus Model 4021 (510(k) K900461 and K952363, ELA Medical Inc.) and 4024 pacemakers (510(k) K882391 and K952364, ELA Medical Inc.). Description of Conditions fo…	Ela Medical, Inc.	1990	—
*	K952363	Opus Pacemakers (Models 4021, 4033, and 4034) Summary page 1 …erine G. Goble 510(k) Number: K970072 Date of Judgment of Substantial Equivalence Sent to Applicant: Predicate Devices: ELA Medical Opus Model 4021 (510(k) K900461 and K952363, ELA Medical Inc.) and 4024 pacemakers (510(k) K882391 and K952364, ELA Medical Inc.). Description of Conditions for Which the…	Ela Medical, Inc.	1995	—
*	K882391	Opus 3 Pulse Generators Models 4003,4004,4023,4024 Summary page 1 …of Substantial Equivalence Sent to Applicant: Predicate Devices: ELA Medical Opus Model 4021 (510(k) K900461 and K952363, ELA Medical Inc.) and 4024 pacemakers (510(k) K882391 and K952364, ELA Medical Inc.). Description of Conditions for Which the Devices are Indicated Generally accepted indications fo…	Ela Medical, Inc.	1988	—
*	K952364	Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024) Summary page 1 …ial Equivalence Sent to Applicant: Predicate Devices: ELA Medical Opus Model 4021 (510(k) K900461 and K952363, ELA Medical Inc.) and 4024 pacemakers (510(k) K882391 and K952364, ELA Medical Inc.). Description of Conditions for Which the Devices are Indicated Generally accepted indications for long-term…	Ela Medical, Inc.	1995	—

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?

None of the 4 ancestors has a recall.

How does its category compare?

All DXY devices

DXY Implantable Pacemaker Pulse-Generator: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXY

19in 2025

2007high 51 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXY

Too few DXY 510(k)s in any year since 2007 to give a median.

Recalls per year · DXY

4in 2017

2007high 6 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DXY

810in 2025

2007high 6,050 (2011) · low 542 (2016)2025

MAUDE reports naming product code DXY, 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	0	—	0	2,407
2008	0	—	0	2,649
2009	0	—	6	3,750
2010	0	—	1	4,187
2011	0	—	2	6,050
2012	0	—	0	3,709
2013	0	—	0	2,682
2014	0	—	0	5,604
2015	0	—	0	1,022
2016	15	—	0	542
2017	51	—	4	1,047
2018	45	—	0	2,070
2019	19	—	0	1,799
2020	23	—	0	546
2021	20	—	0	560
2022	14	—	0	784
2023	19	—	0	922
2024	20	—	0	773
2025	19	—	0	810
2026	19	—	0	—

What is it indicated for?

AV conduction disorders or intraventricular paroxysmal/permanent conduction disorders with permanent atrial tachycardia: atrial fibrillation or flutter (lead implanted in the ventricle),

Sinus bradycardia, sinoatrial block, brady-tachy syndrome without atrioventricular conduction disorder (lead implanted in the atrium).

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970072 · printed Nov 6, 2026

Cite this page

510(k) Report. “K970072: Opus S Model 4121 and 4124 Pacemakers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970072

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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