510(k) · Cleared

Recalled · 2005

Adapter Cable

K050884510(k) TraditionalCleared May 19, 200542-day reviewClass II21 CFR 870.3720Recalls 1

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

Remington Medical, Inc. · DTA Tester, Pacemaker Electrode Function

Cleared on May 19, 2005 as substantially equivalent to K032613 (Peter M. Rothenberg, M.D., 2003) and 1 other predicate after a 42-day review. Its family tree reaches back 2 generations to 1988. It has been recalled once.

Decided: May 19, 2005
Review: 42 days
Class: Class II
Product code: DTA
Recalls: 1
Predicates: 2

Its longest line of descent runs back 2 generations to K883930 (1988). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK883930 Seamed Model 3300 Dual Chamber Pacing System AnalySeamed Corp. · 1988
1 generation backK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
This deviceK050884 Adapter CableRemington Medical, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K883930	Seamed Model 3300 Dual Chamber Pacing System Analy	Seamed Corp.	1988	—
−1	K964190	Era 300 Dual Chamber Pacing System Analyzer	Biotronik, Inc.	1997	—
0 (this device)	K050884	Adapter Cable	Remington Medical, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
2003	1	0

FIG. 1 — Lineage of K050884, 1988–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DTA? 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? (2)

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	Applicant	Decided	Recalls
*	K032613	Temporary Transvenous Pacemaker Placement Assist Device Summary page 1 …r: 870.3600, 870.3630, and 870.3720 C. Identification of Legally Marketed Devices 1. Name: ERA 300 2. K Number: K032613 and K964190 3. Date Cleared: December 8, 2003 and July 10, 1997 D. Description of the Device…	Peter M. Rothenberg, M.D.	2003	—
*	K964190	Era 300 Dual Chamber Pacing System Analyzer Summary page 1 …870.3600, 870.3630, and 870.3720 C. Identification of Legally Marketed Devices 1. Name: ERA 300 2. K Number: K032613 and K964190 3. Date Cleared: December 8, 2003 and July 10, 1997 D. Description of the Device…	Biotronik, Inc.	1997	—

Also cleared against K032613: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 31, 2005	Not classified	Z-0124-06	Other	The vector selector has an electrical design flaw which prevents RV pacing.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 8.7 years on median.
None of the 4 ancestors has a recall.
1 other device also cites its predicate K032613.

How does its category compare?

All DTA devices

DTA Tester, Pacemaker Electrode Function: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTA

1in 2017

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTA

Too few DTA 510(k)s in any year since 2007 to give a median.

Recalls per year · DTA

No recall names DTA since 2007.

Adverse event reports per year · DTA

1in 2023

2007high 2 (2013) · low 0 (2007)2025

MAUDE reports naming product code DTA, 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	1	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	1
2011	0	—	0
2012	0	—	0
2013	0	—	2
2014	0	—	0
2015	0	—	1
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	1
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K050884 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050884: Adapter Cable.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050884

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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