510(k) · Cleared

Cleared

Medtronic Model 5311B a-V Pacing System Analyzer

K884331510(k) TraditionalCleared Jan 10, 198988-day reviewClass II21 CFR 870.3630

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

Medtronic Vascular · DTC Analyzer, Pacemaker Generator Function

Cleared on Jan 10, 1989 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 13 later devices descend from it.

Decided: Jan 10, 1989
Review: 88 days
Class: Class II
Product code: DTC
Recalls: None
Predicates: 0

13 later devices descend from it, 2 citing it directly.

This deviceK884331 Medtronic Model 5311B a-V Pacing System AnalyzerMedtronic Vascular · 1989
Descendant · cites it directly · 9 of its ownK964190 Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997
Descendant · 2 generations on · 4 of its ownK022360 Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000…Biotronik, Inc. · 2003
Descendant · cites it directly · 2 of its ownK971474 Medtronic Model 5318 Temporary Pacemaker/Implant ToolMedtronic Vascular · 1997
Descendant · 2 generations on · 1 of its ownK182839 Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019
Descendant · 3 generations on · 1 of its ownK083674 PK-141 Patient CableBiotronik, Inc. · 2009

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

1997high 2 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 13 · See all

K964190Era 300 Dual Chamber Pacing System AnalyzerBiotronik, Inc. · 1997 · cites it directly9descendants
K022360Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger; Era 3000…Biotronik, Inc. · 2003 · 2 generations on4descendants
K971474Medtronic Model 5318 Temporary Pacemaker/Implant ToolMedtronic Vascular · 1997 · cites it directly2descendants
K182839Lifetech Cardio Model 8301 Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd. · 2019 · 2 generations on1descendant
K083674PK-141 Patient CableBiotronik, Inc. · 2009 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K884331	Medtronic Model 5311B a-V Pacing System Analyzer	Medtronic Vascular	1989	—
+1	K964190	Era 300 Dual Chamber Pacing System Analyzer	Biotronik, Inc.	1997	—
+2	K022360	Era 3000; PA-2 IS-1 Adapter; EK-4-N Pacemaker Test Cable; Era 3000 Charger…	Biotronik, Inc.	2003	—
+1	K971474	Medtronic Model 5318 Temporary Pacemaker/Implant Tool	Medtronic Vascular	1997	—
+2	K182839	Lifetech Cardio Model 8301 Temporary Pacemaker	Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.	2019	—
+3	K083674	PK-141 Patient Cable	Biotronik, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0
2003	2	0
2004	1	0
2005	1	0
2007	1	0
2009	1	0
2010	1	0
2013	1	0
2017	1	0
2019	1	0
2024	1	0

FIG. 1 — Lineage of K884331, 1989–2024Source: 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 DTC? 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? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K964190	Era 300 Dual Chamber Pacing System Analyzer	Biotronik, Inc.	1997	9
K971474	Medtronic Model 5318 Temporary Pacemaker/Implant Tool	Medtronic Vascular	1997	2

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, K964190 (Biotronik, Inc., 1997) has gone furthest, with 9 descendants of its own.

How does its category compare?

All DTC devices

DTC Analyzer, Pacemaker Generator Function: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DTC

1in 2017

2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTC

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

Recalls per year · DTC

No recall names DTC since 2007.

Adverse event reports per year · DTC

1,159in 2025

2007high 1,159 (2025) · low 0 (2007)2025

MAUDE reports naming product code DTC, 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	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	2
2011	0	—	1
2012	0	—	0
2013	0	—	0
2014	0	—	1
2015	0	—	0
2016	0	—	0
2017	1	—	34
2018	0	—	22
2019	0	—	138
2020	0	—	189
2021	0	—	636
2022	0	—	218
2023	0	—	215
2024	0	—	1,076
2025	0	—	1,159
2026	0	—	—

https://510kreport.com/device/K884331 · printed Nov 3, 2026

Cite this page

510(k) Report. “K884331: Medtronic Model 5311B a-V Pacing System Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K884331

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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