510(k) Report

510(k) · Cleared

Cleared

Focus T41,T41F,T43, T43F,T44F

K904255510(k) TraditionalCleared Jan 18, 1991123-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

Elamedical · DTB Permanent Pacemaker Electrode

Cleared on Jan 18, 1991 after a 123-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 18, 1991
Review
123 days
Class
Class III
Product code
DTB
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2000: 1 descendant cleared1990200020102020
  1. This deviceK904255 Focus T41,T41F,T43, T43F,T44FElamedical · 1991
  2. Descendant · cites it directly · 0 of its ownK993448 Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and…Ela Medical, Inc. · 2000
  3. Descendant · cites it directly · 0 of its ownK963738 Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc. · 1997

Most influential descendants

Showing 2 of 2 · See all
  • K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…Ela Medical, Inc. · 2000 · cites it directly0descendants
  • K963738Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc. · 1997 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904255Focus T41,T41F,T43, T43F,T44FElamedical1991—
+1K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45…Ela Medical, Inc.2000—
+1K963738Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc.1997—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200010
FIG. 1 — Lineage of K904255, 1991–2000Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K993448Stela UT46 and BT45/46 Straight Tined Pacing Leads, Stela UJ45 and BJ44/45 J-Shaped…Ela Medical, Inc.20000
K963738Stela Model BJ44 and BJ45 Pacing LeadsEla Medical, Inc.19970

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?

  • Of its descendants, K993448 (Ela Medical, Inc., 2000) has gone furthest, with 0 descendants of its own.

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—

Recent decisions in DTB

The DTB category page

https://510kreport.com/device/K904255 · printed Nov 5, 2026

Cite this page

510(k) Report. “K904255: Focus T41,T41F,T43, T43F,T44F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904255

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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