510(k) Report

510(k) · Cleared

Cleared

Implantable Endocardial Pacing Leads

K831926510(k) TraditionalCleared Mar 12, 1984271-day reviewClass I21 CFR 870.3690

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

Oscor, Inc. · DTG Magnet, Test, Pacemaker

Cleared on Mar 12, 1984 after a 271-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 12, 1984
Review
271 days
Class
Class I
Product code
DTG
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K831926Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DTG? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All DTG devices

DTG Magnet, Test, Pacemaker: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTG

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTG

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

Recalls per year · DTG

No recall names DTG since 2007.

Adverse event reports per year · DTG

3in 2024

2014: 12015: 22018: 12019: 22021: 12023: 12024: 3
2007high 3 (2024) · low 0 (2007)2025

MAUDE reports naming product code DTG, 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—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—01
20150—02
20160—00
20170—00
20180—01
20190—02
20200—00
20210—01
20220—00
20230—01
20240—03
20250—00
20260—0—

More from Oscor, Inc.

49 FDA decisions under this applicant name. See the company

  • K210627Breezeway IIOscor, Inc. · 2021
  • K151951Destino ReachOscor, Inc. · 2015
  • K143463IS4/DF4 Port PlugOscor, Inc. · 2015
  • K140917Introducer, Model Adelante MagnumOscor, Inc. · 2014
  • K140406Destino Twist, Steerable Guiding SheathOscor, Inc. · 20141 recall

Recent decisions in DTG

The DTG category page

  • K092364Model 220 Patient MagnetCyberonics, Inc. · 2009
  • K960849Magno AlarmCardiac Assist Devices, Inc. · 1997
  • K895110Maestro Pacemaker Test MagnetCardiac Control Systems, Inc. · 1989
  • K813153Test MagnetPacesetter Systems · 1981

https://510kreport.com/device/K831926 · printed Nov 6, 2026

Cite this page

510(k) Report. “K831926: Implantable Endocardial Pacing Leads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K831926

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026