510(k) · Cleared
ClearedBK-a; BK-B; BK-IS Sealing Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biotronik, Inc. · DTD Pacemaker Lead Adaptor
Cleared on Apr 29, 1997 after a 98-day review. The FDA summary names no predicate by number.
- Decided
- Apr 29, 1997
- Review
- 98 days
- Class
- Class II
- Product code
- DTD
- 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 DTD? 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 DTD devicesDTD Pacemaker Lead Adaptor: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DTD
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · DTD
Too few DTD 510(k)s in any year since 2007 to give a median.
Recalls per year · DTD
No recall names DTD since 2007.
Adverse event reports per year · DTD
32in 2025
MAUDE reports naming product code DTD, 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 | 8 |
| 2008 | 0 | — | 0 | 8 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 0 | — | 0 | 36 |
| 2011 | 0 | — | 0 | 18 |
| 2012 | 0 | — | 0 | 19 |
| 2013 | 1 | — | 0 | 30 |
| 2014 | 0 | — | 0 | 21 |
| 2015 | 1 | — | 0 | 41 |
| 2016 | 0 | — | 0 | 20 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 0 | — | 0 | 34 |
| 2020 | 0 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 23 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 0 | — | 0 | 28 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 32 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K970204 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970204: BK-a; BK-B; BK-IS Sealing Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970204
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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