510(k) Report

510(k) · Cleared

Recalled · 2008

Permanent Pacing Lead, Model Refino, Model: Refino-R, RU, Rju

K040569510(k) SpecialCleared Apr 7, 200434-day reviewClass III21 CFR 870.3680Recalls 1

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

Oscor, Inc. · DTB Permanent Pacemaker Electrode

Cleared on Apr 7, 2004 after a 34-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled once.

Decided
Apr 7, 2004
Review
34 days
Class
Class III
Product code
DTB
Recalls
1
Predicates
0

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

FIG. 1 — Lineage of K040569Source: 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), 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.

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

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jan 29, 2008Not classifiedZ-2333-2008Nonconforming Material/ComponentThe O-rings are over tolerance making it hard to connect the leads to the pacemaker.

No ancestor or descendant has a Class I recall.

How does its category compare?

All DTB devices

DTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTB

1in 2025

2015: 32016: 82017: 52018: 62019: 72020: 62021: 32022: 42023: 72024: 32025: 12026 (partial year): 2
2007high 8 (2016) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTB

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

Recalls per year · DTB

1in 2015

2008: 12009: 22010: 22015: 1
2007high 2 (2009) · low 0 (2007)2026

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

Adverse event reports per year · DTB

25,591in 2025

2007: 5,4012008: 6,4692009: 7,5652010: 14,2852011: 12,5552012: 12,2302013: 10,1022014: 13,3242015: 11,0712016: 11,8392017: 11,4952018: 15,2092019: 16,8122020: 17,8592021: 18,4422022: 19,4442023: 34,5422024: 25,6892025: 25,591
2007high 34,542 (2023) · low 5,401 (2007)2025

MAUDE reports naming product code DTB, 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—05,401
20080—16,469
20090—27,565
20100—214,285
20110—012,555
20120—012,230
20130—010,102
20140—013,324
20153—111,071
20168—011,839
20175—011,495
20186—015,209
20197—016,812
20206—017,859
20213—018,442
20224—019,444
20237—034,542
20243—025,689
20251—025,591
20262—0—

What is it indicated for?

Permanent pacing lead, Model Refino TM is indicated for pacing and sensing of

the ventricle and / or atrium of the heart. The lead is used in conjunction with a

compatible implantable pulse generator (pacemaker).

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

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 DTB

The DTB category page

https://510kreport.com/device/K040569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040569: Permanent Pacing Lead, Model Refino, Model: Refino-R, RU, Rju.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040569

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026