510(k) Report

510(k) · Cleared

Recalled · Class I · 2017

Electrode/Extension Cables, Models Atar

K070926510(k) SpecialCleared Jun 7, 200765-day reviewClass II21 CFR 890.1175Recalls 2 (2 Class I)

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

Oscor, Inc. · IKD Cable, Electrode

Cleared on Jun 7, 2007 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 of the 2 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 2 times, including 2 Class I recalls.

Decided
Jun 7, 2007
Review
65 days
Class
Class II
Product code
IKD
Recalls
2 (2 Class I)
Predicates
0

1 later device descends from it, 1 citing it directly. 1 of the 2 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2020: 1 descendant cleared20052010201520202025
  1. This deviceK070926 Electrode/Extension Cables, Models AtarOscor, Inc. · 2007
  2. Descendant · cites it directly · 0 of its ownK200674 AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp -…Atrility Medical, LLC · 2020

Most influential descendants

Showing 1 of 1 · See all
  • K200674AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor…Atrility Medical, LLC · 2020 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K070926Electrode/Extension Cables, Models AtarOscor, Inc.2007—
+1K200674AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable…Atrility Medical, LLC2020—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
FIG. 1 — Lineage of K070926, 2007–2020Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K200674AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor…Atrility Medical, LLC20200

Has anything in its family been recalled? (1 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2017Class IZ-2733-2017Process controlThe Reusable Oscor ATAR extension cables could separate from the connector during use.
Mar 31, 2017Class IZ-2340-2017Process controlThe Reusable Oscor ATAR extension cables could separate from the connector during use.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K200674 (Atrility Medical, LLC, 2020) has gone furthest, with 0 descendants of its own.

How does its category compare?

All IKD devices

IKD Cable, Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IKD

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IKD

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

Recalls per year · IKD

1in 2019

2008: 12011: 22019: 1
2007high 2 (2011) · low 0 (2007)2026

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

Adverse event reports per year · IKD

42in 2025

2007: 32008: 42009: 52010: 22011: 22012: 32013: 42014: 32015: 32016: 572017: 332018: 52019: 42020: 72021: 122022: 172023: 72024: 102025: 42
2007high 57 (2016) · low 2 (2010)2025

MAUDE reports naming product code IKD, 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
20071—03
20080—14
20090—05
20100—02
20110—22
20120—03
20130—04
20140—03
20150—03
20160—057
20170—033
20180—05
20190—14
20200—07
20210—012
20220—017
20230—07
20240—010
20250—042
20260—0—

What is it indicated for?

Electrode/extension cable is intended to connect an electrode/lead from a patient or another cable to a diagnostic machine or an external pacemaker.

Indications for use as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K070926: Electrode/Extension Cables, Models Atar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070926

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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