510(k) · Cleared

Cleared

A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace.

K902889510(k) TraditionalCleared Aug 23, 199052-day reviewClass II21 CFR 870.3620

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Biotronik, GmbH & Co. · DTD Pacemaker Lead Adaptor

Cleared on Aug 23, 1990 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Aug 23, 1990
Review: 52 days
Class: Class II
Product code: DTD
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK902889 A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace.Biotronik, GmbH & Co. · 1990
Descendant · cites it directly · 0 of its ownK970388 A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter SleeveBiotronik, Inc. · 1997

Most influential descendants

Showing 1 of 1 · See all

K970388A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter SleeveBiotronik, Inc. · 1997 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K902889	A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace.	Biotronik, GmbH & Co.	1990	—
+1	K970388	A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter Sleeve	Biotronik, Inc.	1997	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K902889, 1990–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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

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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? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K970388	A1-a,Abp,B,MBP, Lead Connectors; Peh Adapter Sleeve	Biotronik, Inc.	1997	0

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, K970388 (Biotronik, Inc., 1997) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DTD devices

DTD Pacemaker Lead Adaptor: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTD

1in 2015

2007high 1 (2013) · low 0 (2007)2026

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

2007high 41 (2015) · low 8 (2007)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	MAUDE reports
2007	0	—	8
2008	0	—	8
2009	0	—	8
2010	0	—	36
2011	0	—	18
2012	0	—	19
2013	1	—	30
2014	0	—	21
2015	1	—	41
2016	0	—	20
2017	0	—	16
2018	0	—	29
2019	0	—	34
2020	0	—	19
2021	0	—	23
2022	0	—	25
2023	0	—	28
2024	0	—	35
2025	0	—	32
2026	0	—	—

https://510kreport.com/device/K902889 · printed Nov 6, 2026

Cite this page

510(k) Report. “K902889: A1-a,A1-B,A1-Abp,A1-MBP,A1-Z,A6-a,A6-B,Peh Pace..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K902889

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Record history

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