510(k) · Cleared
ClearedA1-a,Abp,B,MBP, Lead Connectors; Peh Adapter Sleeve
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 Aug 14, 1997 as substantially equivalent to K902889 (Biotronik, GmbH & Co., 1990) after a 192-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Aug 14, 1997
- Review
- 192 days
- Class
- Class II
- Product code
- DTD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902889 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902889 A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace.Biotronik, GmbH & Co. · 1990
- This deviceK970388 A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter SleeveBiotronik, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902889 | A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace. | Biotronik, GmbH & Co. | 1990 | — |
| 0 (this device) | K970388 | A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter Sleeve | Biotronik, Inc. | 1997 | — |
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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K902889 | A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace.Summary page 3…s provided to BIOTRONIK, nor was BIOTRONIK provided the opportunity to examine the explanted device. 1.3 Previous 510(k) Submittals In a letter dated August 23, 1990 (#K902889), FDA provided notification it had determined the Al Series Lead Adapters and PEH Adapter Sleeves were Class Il devices substanti… | 1990 |
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?
- Its one ancestor has no 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 | — |
What is it indicated for?
Lead adapters, including silicone adapter sleeves, when used in conjunction with their accessories, provide a means of securely connecting pace/sense leads with otherwise mechanically incompatible pacemaker devices.
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/K970388 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970388: A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970388
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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