510(k) Report

510(k) · Cleared

Cleared

Model 4951M Myocardial Unipolar Lead

K031210510(k) SpecialCleared May 16, 200329-day reviewClass III21 CFR 870.3680

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

Metronic, Inc. · DTB Permanent Pacemaker Electrode

Cleared on May 16, 2003 after a 29-day review. The FDA summary names its predicate without a number.

Decided
May 16, 2003
Review
29 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K031210Source: 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 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 DTB? 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? (1)

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
*—Model 4951M Lead
Named without a submission number
—
†K894040Implantable Pacing Leads W/IS-1 Conn., UnipolarMedtronic Vascular1989—
†K913288Medtronic Unipolar, Poly Pac Lead-Barr Coat CoilsMedtronic Vascular1991—

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 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?

The Medtronic Model 495 1M Myocardial, IS- 1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.

Indications for use as stated in the FDA summary.

More from Metronic, Inc.

4 FDA decisions under this applicant name. See the company

  • K911827Model 5866-9M & Model 6981MMetronic, Inc. · 1991
  • K874884Medtronic (R) Orthoflex (TM)Metronic, Inc. · 1988
  • K832505Image Processing Sys A3Metronic, Inc. · 1983

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K031210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031210: Model 4951M Myocardial Unipolar Lead.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031210

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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