510(k) · Cleared

Cleared

Guidant Syncrus Internal Cardioversion System

K024071510(k) SpecialCleared Feb 14, 200366-day reviewClass II21 CFR 870.3680

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

Guidant Corporation, Cardiac Surgery · NHW Electrode, Pacing And Cardioversion, Temporary, Epicardial

Cleared on Feb 14, 2003 as substantially equivalent to K020701 (Guidant Corporation, Cardiac Surgery, 2002) after a 66-day review. Its family tree reaches back 2 generations to 1980.

Decided: Feb 14, 2003
Review: 66 days
Class: Class II
Product code: NHW
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K800937 (1980). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK800937 R2 Plate Type Cable-Adaptor #S 175,176R2 Corp. · 1980
1 generation backK020701 Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002
This deviceK024071 Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K800937	R2 Plate Type Cable-Adaptor #S 175,176	R2 Corp.	1980	—
−1	K020701	Syncrus Internal Cardioversion System	Guidant Corporation, Cardiac Surgery	2002	—
0 (this device)	K024071	Guidant Syncrus Internal Cardioversion System	Guidant Corporation, Cardiac Surgery	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1995	1	0

FIG. 1 — Lineage of K024071, 1980–2003Source: 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 NHW? 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? (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
*	K020701	Syncrus Internal Cardioversion System Summary page 2 …cular pacing/sensing and/or atrial cardioversion. G. Substantial Equivalence Guidant proposes that the Syncrus System is substantially equivalent to the Syncrus System (K020701). The subject device is substantially equivalent to the predicate device with regard to intended use, indications, device charact…	Guidant Corporation, Cardiac Surgery	2002	—

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 23 years and passes through 2 companies; a new generation was cleared every 22.0 years on median.
None of the 4 ancestors has a recall.

How does its category compare?

All NHW devices

NHW Electrode, Pacing And Cardioversion, Temporary, Epicardial: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHW

FDA has decided no NHW device since 2007.

Median 510(k) review, days · NHW

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

Recalls per year · NHW

No recall names NHW since 2007.

Adverse event reports per year · NHW

1in 2023

2007high 50 (2011) · low 0 (2007)2025

MAUDE reports naming product code NHW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	3
2009	—	4
2010	—	14
2011	—	50
2012	—	23
2013	—	25
2014	—	0
2015	—	1
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	1
2023	—	1
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The Guidant SYNCRUS™ Internal Cardioversion System is indicated for use in post-operative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K024071 · printed Nov 6, 2026

Cite this page

510(k) Report. “K024071: Guidant Syncrus Internal Cardioversion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024071

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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