510(k) Report

FDA product code · Cardiovascular

Electrode, Pacing And Cardioversion, Temporary, Epicardial

NHWClass II21 CFR 870.3680510(k) required2 decisions since 20020 recalls

2 FDA decisions since 2002. No recall names this code. The most-cited predicate is K020701, named by 1 later device.

The System is indicated for use in postoperative cardiac surgery patients who require temporary atrial or ventricular pacing/sensing and/or atrial cardioversion. Epicardial defibrillation electrodes can be implanted up to 7 days.

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

FIG. A — Illustration, cardiovascular panel

Twenty years of NHW at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

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—
FIG. 1 — NHW by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in NHW? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which predicates do NHW devices cite most?

Devices in this code that later submissions most often claim equivalence to.

  • K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 20021cites it

Which NHW devices have the deepest lineage?

Devices in this code with the longest line of descent behind them.

  • K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 20032generations
  • K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 20021generation

What has FDA decided in NHW lately?

  • K024071Guidant Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2003
  • K020701Syncrus Internal Cardioversion SystemGuidant Corporation, Cardiac Surgery · 2002

All 2 NHW decisions →

Related product codes

Other codes under 21 CFR 870.3680.

LDF Electrode, Pacemaker, TemporaryDTB Permanent Pacemaker Electrode