510(k) Report

510(k) · Cleared

Cleared

Syncrus Internal Cardioversion System

K020701510(k) TraditionalCleared May 24, 200281-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 May 24, 2002 as substantially equivalent to K944957 (Medtronic Blood Systems, Inc., 1995) and 2 other predicates after an 81-day review. Its family tree reaches back 1 generation to 1980. 1 later device descends from it.

Decided
May 24, 2002
Review
81 days
Class
Class II
Product code
NHW
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K800937 (1980). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 1 other ancestor1993: 1 other ancestor2003: 1 descendant clearedK800937 · R2 Plate Type Cable-Adaptor #S 175,176 · R2 Corp. · 198019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 1 descendant K800937 · R2 Plate Type Cable-Adaptor #S 175,176 · R2 Corp. · 19800
  1. Root · 1 generation backK800937 R2 Plate Type Cable-Adaptor #S 175,176R2 Corp. · 1980
  2. This deviceK020701 Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002
  3. Descendant · cites it directly · 0 of its ownK024071 Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003

Most influential descendants

Showing 1 of 1 · See all
  • K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K800937R2 Plate Type Cable-Adaptor #S 175,176R2 Corp.1980—
0 (this device)K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery2002—
+1K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
FIG. 1 — Lineage of K020701, 1980–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K944957Temporary Myocardial Pacing Lead, Model 6500
Summary page 3
…2 Cable Adapter. The Medtronic Pacing & Sensing Wires have received clearance for temporary operative/post-operative cardiac pacing and intracardiac ECG monitoring under K944957. The Physio-Control LifePak 9 External Defibrillator, including the internal paddle accessory, has received clearance for use in…
Medtronic Blood Systems, Inc.1995—
*K935674Lifepak 9 Defibrillator/Monitor
Summary page 3
…ol LifePak 9 External Defibrillator, including the internal paddle accessory, has received clearance for use in the diagnosis and treatment of cardiac dysrhythmias under K935674. The R2 Cable Adapter has received clearance for use in defibrillation and cardioversion.under K800937. Device Testing Results a…
Physio-Control Corp.1993—
*K800937R2 Plate Type Cable-Adaptor #S 175,176
Summary page 3
…r use in the diagnosis and treatment of cardiac dysrhythmias under K935674. The R2 Cable Adapter has received clearance for use in defibrillation and cardioversion.under K800937. Device Testing Results and Conclusions: All necessary testing was performed on the Guidant Syncrus System to ensure that the sy…
R2 Corp.1980—

Also cleared against K944957: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery20030

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 3 ancestors has a recall.
  • Of its descendants, K024071 (Guidant Corporation, Cardiac Surgery, 2003) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K944957.

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

2008: 32009: 42010: 142011: 502012: 232013: 252015: 12017: 12022: 12023: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20090—04
20100—014
20110—050
20120—023
20130—025
20140—00
20150—01
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—01
20230—01
20240—00
20250—00
20260—0—

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

Also cleared against K944957

1 other device cites the same predicate.

  • K963898Model 6495 Bipolar Temporary Pacing LeadMedtronic Vascular · 19971 recall

More from Guidant Corporation, Cardiac Surgery

8 FDA decisions under this applicant name. See the company

  • K080169Heartstring Iii Proximal Seal SystemGuidant Corporation, Cardiac Surgery · 2008
  • K041340Guidant Microwave Ablation SystemGuidant Corporation, Cardiac Surgery · 2004
  • K023630Essex Aspiration/Irrigation Instrument with Positioning Guide, Model SY-1400Guidant Corporation, Cardiac Surgery · 2003
  • K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003
  • K023629Essex Dissection Cannula, Model SXD-1100, Essex Dissection Tip, Model SXD-1200Guidant Corporation, Cardiac Surgery · 2002

Recent decisions in NHW

The NHW category page

  • K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003

https://510kreport.com/device/K020701 · printed Nov 4, 2026

Cite this page

510(k) Report. “K020701: Syncrus Internal Cardioversion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020701

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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