510(k) · Cleared
ClearedHT, Model HT PB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sulzer Oscor, Inc. · DTB Permanent Pacemaker Electrode
Cleared on Jul 30, 1999 after a 192-day review. The FDA summary names no predicate by number.
- Decided
- Jul 30, 1999
- Review
- 192 days
- Class
- Class III
- Product code
- DTB
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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
What was it cleared against?
The FDA summary names no predicate by number.
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 devicesDTB Permanent Pacemaker Electrode: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTB
1in 2025
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DTB
25,591in 2025
MAUDE reports naming product code DTB, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 5,401 |
| 2008 | 0 | — | 1 | 6,469 |
| 2009 | 0 | — | 2 | 7,565 |
| 2010 | 0 | — | 2 | 14,285 |
| 2011 | 0 | — | 0 | 12,555 |
| 2012 | 0 | — | 0 | 12,230 |
| 2013 | 0 | — | 0 | 10,102 |
| 2014 | 0 | — | 0 | 13,324 |
| 2015 | 3 | — | 1 | 11,071 |
| 2016 | 8 | — | 0 | 11,839 |
| 2017 | 5 | — | 0 | 11,495 |
| 2018 | 6 | — | 0 | 15,209 |
| 2019 | 7 | — | 0 | 16,812 |
| 2020 | 6 | — | 0 | 17,859 |
| 2021 | 3 | — | 0 | 18,442 |
| 2022 | 4 | — | 0 | 19,444 |
| 2023 | 7 | — | 0 | 34,542 |
| 2024 | 3 | — | 0 | 25,689 |
| 2025 | 1 | — | 0 | 25,591 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The tined passive tip permanent lead is indicated for ventricular placement. The lead is used in conjunction with an implantable pulse generator. A variety of pulse generators can be used in combination with the lead. The lead will connect directly to many commercially available pulse generators. Some pulse generators require the use of a commercially available adapter to make the connection to the lead.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K990142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990142: HT, Model HT PB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990142
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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