510(k) · Cleared

Cleared

Ensite Velocity System

K101328510(k) SpecialCleared Jul 14, 201064-day reviewClass II21 CFR 870.1425

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

St Jude Medical · DQK Computer, Diagnostic, Programmable

Cleared on Jul 14, 2010 as substantially equivalent to K093942 (St Jude Medical, 2010) after a 64-day review. Its family tree reaches back 1 generation to 2010. 34 later devices descend from it.

Decided: Jul 14, 2010
Review: 64 days
Class: Class II
Product code: DQK
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K093942 (2010). 34 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK093942 Ensite Velocity System V1.3St Jude Medical · 2010
This deviceK101328 Ensite Velocity SystemSt Jude Medical · 2010
Descendant · cites it directly · 33 of its ownK103746 Carto 3 EP Navigation System, Version 2.0 (W/Standard Location…Biosense Webster, Inc. · 2011 · Recalled
Descendant · 2 generations on · 32 of its ownK112007 Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · Recalled
Descendant · 3 generations on · 31 of its ownK120550 Carto (R) EP Navigation System, Version 3.0 (with Standard Location…Biosense Webster, Inc. · 2012 · Recalled
Descendant · 4 generations on · 27 of its ownK133916 Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · Recalled
Descendant · 5 generations on · 20 of its ownK170600 CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017

Showing 5 of 34 descendants. See all descendants

Descendants cleared per year

2011high 5 (2018) · low 0 (2013)2026

Most influential descendants

Showing 5 of 34 · See all

K103746Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…Biosense Webster, Inc. · 2011 · cites it directly33descendants
K112007Carto 3 EP Navigation System, Version 2.2Biosense Webster, Inc. · 2011 · 2 generations on32descendants
K120550Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)Biosense Webster, Inc. · 2012 · 3 generations on31descendants
K133916Carto 3 EP Navigation System, Version 4.2Biosense Webster, Inc. · 2014 · 4 generations on27descendants
K170600CARTO 3 EP Navigation System, Version 6.0 and AccessoriesBiosense Webster, Inc. · 2017 · 5 generations on20descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K093942	Ensite Velocity System V1.3	St Jude Medical	2010	—
0 (this device)	K101328	Ensite Velocity System	St Jude Medical	2010	—
+1	K103746	Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3…	Biosense Webster, Inc.	2011	1
+2	K112007	Carto 3 EP Navigation System, Version 2.2	Biosense Webster, Inc.	2011	2
+3	K120550	Carto (R) EP Navigation System, Version 3.0 (with Standard Location Pad)	Biosense Webster, Inc.	2012	2
+4	K133916	Carto 3 EP Navigation System, Version 4.2	Biosense Webster, Inc.	2014	2
+5	K170600	CARTO 3 EP Navigation System, Version 6.0 and Accessories	Biosense Webster, Inc.	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	1	0
2014	2	0
2016	1	0
2017	2	0
2018	5	0
2019	2	0
2020	1	0
2021	1	0
2022	2	0
2023	3	0
2024	4	0
2025	3	0
2026	5	0

FIG. 1 — Lineage of K101328, 2010–2026Source: 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 DQK? 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 DQK device

#1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 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? (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	Applicant	Decided	Recalls
*	K093942	Ensite Velocity System V1.3 Summary page 1 …Medical One St. Jude Medical Drive St. Paul, MN 55117 USA The Establishment Registration Number is 2184149. 12.2 Predicate Device EnSite Velocity System v. 1.3 (K093942) 12.3 Common or Usual Name Electrophysiology Mapping System with console and catheter 12.4 Proprietary Name EnSit…	St Jude Medical	2010	—

Also cleared against K093942: 2 other devices →

What descends from it? (34)

See all 34

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

Number	Device	Applicant	Decided	Descendants
K103746	Carto 3 EP Navigation System, Version 2.0 (W/Standard Location Pad),CARTO3 Epnavigation…	Biosense Webster, Inc.	2011	33

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.
Of its descendants, K103746 (Biosense Webster, Inc., 2011) has gone furthest, with 33 descendants of its own.
2 other devices also cite its predicate K093942.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007high 190 (2016) · low 64 (2010)2026

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

Recalls per year · DQK

1in 2025

2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, 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	13	83	4	18
2008	4	70	1	34
2009	12	93	2	40
2010	9	64	3	49
2011	12	69	2	55
2012	7	74	3	129
2013	13	68	1	180
2014	9	90	4	115
2015	7	125	2	131
2016	15	190	0	340
2017	7	146	2	252
2018	14	150	6	261
2019	15	113	1	218
2020	16	123	1	215
2021	16	132	1	351
2022	19	136	2	319
2023	21	133	2	340
2024	13	100	24	557
2025	22	95	1	433
2026	23	151	2	—

What is it indicated for?

The EnSite Velocity Cardiac Mapping System is a suggested diagnostic tool in patients for whom electrophysiology studies are indicated.

*When used with the EnSite Array Catheter, the EnSite System is intended to be used in the right atrium of patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

* When used with the EnSite NavX Surface Electrode Kit, the EnSite System is intended to display the position of conventional electrophysiology (EP) catheters in the heart.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101328 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101328: Ensite Velocity System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101328

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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