510(k) · Cleared

Cleared

Elecath Percutaneous Left Atrial Cannulation Set

K854511510(k) TraditionalCleared Feb 10, 198690-day reviewClass II21 CFR 870.1330

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

Electro-Catheter Corp. · DQX Wire, Guide, Catheter

Cleared on Feb 10, 1986 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 12 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.

Decided: Feb 10, 1986
Review: 90 days
Class: Class II
Product code: DQX
Recalls: None
Predicates: 0

11 later devices descend from it, 1 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.

This deviceK854511 Elecath Percutaneous Left Atrial Cannulation SetElectro-Catheter Corp. · 1986
Descendant · cites it directly · 10 of its ownK030398 Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003
Descendant · 2 generations on · 9 of its ownK052570 Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · Recalled
Descendant · 3 generations on · 7 of its ownK063723 Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008
Descendant · 4 generations on · 3 of its ownK083111 Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · Recalled
Descendant · 5 generations on · 2 of its ownK102726 Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · Recalled (Class I)

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 2 (2008) · low 0 (2004)2026

Class I recalls in this family

K102726 Cardiohelp System5 generations on · 2011
K133598 Cardiohelp System6 generations on · 2014

Most influential descendants

Showing 5 of 11 · See all

K030398Cardiacassist Transseptal Cannula Set, Model 5132-6221Cardiacassist, Inc. · 2003 · cites it directly10descendants
K052570Tandemheart Transseptal Cannula Set-EF, Model 5140-6221Cardiacassist, Inc. · 2006 · 2 generations on9descendants
K063723Impella Recover LP 2.5 Percutaneous Cardiac Support SystemAbiomed, Inc. · 2008 · 3 generations on7descendants
K083111Impella 5.0 Catheter FamilyAbiomed, Inc. · 2009 · 4 generations on3descendants
K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 5 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K854511	Elecath Percutaneous Left Atrial Cannulation Set	Electro-Catheter Corp.	1986	—
+1	K030398	Cardiacassist Transseptal Cannula Set, Model 5132-6221	Cardiacassist, Inc.	2003	—
+2	K052570	Tandemheart Transseptal Cannula Set-EF, Model 5140-6221	Cardiacassist, Inc.	2006	1
+3	K063723	Impella Recover LP 2.5 Percutaneous Cardiac Support System	Abiomed, Inc.	2008	—
+4	K083111	Impella 5.0 Catheter Family	Abiomed, Inc.	2009	1
+5	K102726	Cardiohelp System	Maquet Cardiopulmonary, AG	2011	Class I

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0
2008	2	0
2009	1	0
2010	1	0
2011	2	1
2012	1	0
2013	1	0
2014	1	1

FIG. 1 — Lineage of K854511, 1986–2014Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQX device

#1 K213854 SavvyWirescore 15.7 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin 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? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K030398	Cardiacassist Transseptal Cannula Set, Model 5132-6221	Cardiacassist, Inc.	2003	10

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K102726Cardiohelp SystemMaquet Cardiopulmonary, AG · 2011 · 5 generations on · ◆ in the 2011 descendants bar of FIG. 11 Class I recall
K133598Cardiohelp SystemMaquet Cardiopulmonary, AG · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K030398 (Cardiacassist, Inc., 2003) has gone furthest, with 10 descendants of its own.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQX

10in 2025

2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007high 212 (2022) · low 43 (2011)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQX

3in 2024

2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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	14	85	12	760
2008	19	87	7	715
2009	18	87	49	687
2010	21	63	34	987
2011	18	43	3	1,311
2012	20	62	5	1,337
2013	18	119	7 (4)	1,474
2014	18	103	0	1,323
2015	15	112	1	1,323
2016	14	179	2 (2)	1,466
2017	19	85	17	1,524
2018	19	114	9	1,737
2019	13	173	2	1,679
2020	14	106	1 (1)	1,536
2021	6	161	0	1,713
2022	15	212	0	1,647
2023	10	136	0	2,068
2024	11	134	3	2,210
2025	10	177	0	2,178
2026	12	145	4 (1)	—

https://510kreport.com/device/K854511 · printed Nov 5, 2026

Cite this page

510(k) Report. “K854511: Elecath Percutaneous Left Atrial Cannulation Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K854511

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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