510(k) Report

510(k) · Cleared

Cleared

Stela Model BJ44 and BJ45 Pacing Leads

K963738510(k) TraditionalCleared May 23, 1997248-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

Ela Medical, Inc. · DTB Permanent Pacemaker Electrode

Cleared on May 23, 1997 as substantially equivalent to K904255 (Elamedical, 1991) and 1 other predicate after a 248-day review. Its family tree reaches back 1 generation to 1990.

Decided
May 23, 1997
Review
248 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K896742 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1991: 1 other ancestorK896742 · Focus J81F, J83F, J41F, J43F Pacing Leads · Ela Medical, Inc. · 199019901992199419961998
Other ancestors, by generation 1 generation back: 1 other ancestor K896742 · Focus J81F, J83F, J41F, J43F Pacing Leads · Ela Medical, Inc. · 19900
  1. Root · 1 generation backK896742 Focus J81F, J83F, J41F, J43F Pacing LeadsEla Medical, Inc. · 1990
  2. This deviceK963738 Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K896742Focus J81F, J83F, J41F, J43F Pacing LeadsEla Medical, Inc.1990—
0 (this device)K963738Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
FIG. 1 — Lineage of K963738, 1990–1997Source: 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 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? (2)

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
*K904255Focus T41,T41F,T43, T43F,T44F
Summary page 1
…dgment of Substantial Equivalence Sent to Applicant: Predicate Devices: ELA Medical Focus® Model T44F bipolar tined silicone rubber pacing lead (Document Control Number K904255) and Focus® Model J83F tined silicone rubber pacing lead (Document Control Number K896742). 2.1.2 Description of Conditions for…
Elamedical1991—
*K896742Focus J81F, J83F, J41F, J43F Pacing Leads
Summary page 1
…® Model T44F bipolar tined silicone rubber pacing lead (Document Control Number K904255) and Focus® Model J83F tined silicone rubber pacing lead (Document Control Number K896742). 2.1.2 Description of Conditions for Which the Devices are Indicated The Stela™ Model BJ44 and BJ45 leads are indicated for car…
Ela Medical, Inc.1990—

Also cleared against K904255: 1 other device →

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.

What does this lineage say?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K904255.

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?

ELA Medical endocardial leads are designed to be used with implantable cardiac pacemakers.

ELA Medical Stela ™ Model BJ44 and BJ45 bipolar pacing leads are intended for atrial implantation only.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K904255

1 other device cites the same predicate.

  • K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing LeadsEla Medical, Inc. · 2000

More from Ela Medical, Inc.

43 FDA decisions under this applicant name. See the company

  • K042002Synescope, Easyscope, Synecom, HolterreaderEla Medical, Inc. · 2004
  • K032466SpiderviewEla Medical, Inc. · 2003
  • K002817SynetecEla Medical, Inc. · 2001
  • K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing LeadsEla Medical, Inc. · 2000
  • K000029Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing LeadsEla Medical, Inc. · 2000

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K963738 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963738: Stela Model BJ44 and BJ45 Pacing Leads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963738

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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