510(k) Report

510(k) · Cleared

Cleared

Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing Leads

K993448510(k) TraditionalCleared Apr 10, 2000181-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 Apr 10, 2000 as substantially equivalent to K904255 (Elamedical, 1991) and 2 other predicates after a 181-day review. Its family tree reaches back 2 generations to 1990.

Decided
Apr 10, 2000
Review
181 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K896742 (1990). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1991: 1 other ancestorK896742 · Focus J81F, J83F, J41F, J43F Pacing Leads · Ela Medical, Inc. · 1990K972574 · Stela Model UJ45 Pacing Leads · Ela Medical, Inc. · 19981990199219941996199820002002
Other ancestors, by generation 1 generation back: 2 other ancestors K972574 · Stela Model UJ45 Pacing Leads · Ela Medical, Inc. · 1998K896742 · Focus J81F, J83F, J41F, J43F Pacing Leads · Ela Medical, Inc. · 19900
  1. Root · 2 generations backK896742 Focus J81F, J83F, J41F, J43F Pacing LeadsEla Medical, Inc. · 1990
  2. 1 generation backK972574 Stela Model UJ45 Pacing LeadsEla Medical, Inc. · 1998
  3. This deviceK993448 Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and…Ela Medical, Inc. · 2000
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K896742Focus J81F, J83F, J41F, J43F Pacing LeadsEla Medical, Inc.1990—
−1K972574Stela Model UJ45 Pacing LeadsEla Medical, Inc.1998—
0 (this device)K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45…Ela Medical, Inc.2000—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199710
FIG. 1 — Lineage of K993448, 1990–2000Source: 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? (3)

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
…oble 510(k) Number: K Date of Judgment of Substantial Equivalence Sent to Applicant: Predicate Devices: Device 510(k) Number ELA Medical Stela™ Model BT45/46 and UT46 K904255 ELA Medical Stela™ Model BJ44/BJ45 K963698 ELA Medical Stela™ Model UJ45 K972574 2.1.2 Description of Conditions for Which the D…
Elamedical1991—
*K963698CM02 Cuvette, 1/2, CM02 Cuvette, 3/8 and CM02 Cuvette, 1/4
Summary page 1
…Substantial Equivalence Sent to Applicant: Predicate Devices: Device 510(k) Number ELA Medical Stela™ Model BT45/46 and UT46 K904255 ELA Medical Stela™ Model BJ44/BJ45 K963698 ELA Medical Stela™ Model UJ45 K972574 2.1.2 Description of Conditions for Which the Devices are Indicated The Stela™ Model BT45…
International Biophysics Corp.1997—
*K972574Stela Model UJ45 Pacing Leads
Summary page 1
…ant: Predicate Devices: Device 510(k) Number ELA Medical Stela™ Model BT45/46 and UT46 K904255 ELA Medical Stela™ Model BJ44/BJ45 K963698 ELA Medical Stela™ Model UJ45 K972574 2.1.2 Description of Conditions for Which the Devices are Indicated The Stela™ Model BT45/46, UT46, BJ44/45 and UJ45 pacing lea…
Ela Medical, Inc.1998—

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?

  • The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 7.5 years on median.
  • None of the 4 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 BT45/46 and UT46 straight tined pacing leads are intended for implantation in the ventricle.

ELA Medical Stela™ Model BJ44/45 and UJ45 J-shaped pacing leads are intended for implantation in the atrium.

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.

  • K963738Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc. · 1997

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
  • K000029Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined Pacing LeadsEla Medical, Inc. · 2000
  • K990727Syneflash & SyneviewEla Medical, Inc. · 1999

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K993448 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993448: Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped Tined 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/K993448

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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