510(k) · Cleared

Recalled · Class II · 2016

Transseptal Needle/Trocar

K011727510(k) TraditionalCleared May 2, 2002332-day reviewClass II21 CFR 870.1390Recalls 1

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

Thomas Medical Products, Inc. · DRC Trocar

Cleared on May 2, 2002 after a 332-day review. The FDA summary names its predicate without a number. 28 later devices descend from it. It has been recalled once.

Decided: May 2, 2002
Review: 332 days
Class: Class II
Product code: DRC
Recalls: 1
Predicates: 0

28 later devices descend from it, 4 citing it directly.

This deviceK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002
Descendant · cites it directly · 16 of its ownK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
Descendant · cites it directly · 8 of its ownK072278 BRK Transseptal NeedleSt Jude Medical · 2007
Descendant · 2 generations on · 7 of its ownK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
Descendant · 2 generations on · 6 of its ownK122587 BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207…St Jude Medical · 2013
Descendant · 2 generations on · 3 of its ownK232852 Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023

Showing 5 of 28 descendants. See all descendants

Descendants cleared per year

2006high 6 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 28 · See all

K073326NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · cites it directly16descendants
K072278BRK Transseptal NeedleSt Jude Medical · 2007 · cites it directly8descendants
K150709ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · 2 generations on7descendants
K122587BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical · 2013 · 2 generations on6descendants
K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023 · 2 generations on3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K011727	Transseptal Needle/Trocar	Thomas Medical Products, Inc.	2002	—
+1	K073326	NRG Transseptal Needle	Baylis Medical Co., Inc.	2008	1
+1	K072278	BRK Transseptal Needle	St Jude Medical	2007	—
+2	K150709	ProTrack RF Anchor Wire	Baylis Medical Company, Inc.	2015	1
+2	K122587	BRK Transseptal Needle Model 407200, 407201, 407205, 407206, 407207, G407208	St Jude Medical	2013	—
+2	K232852	Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable	Cross Vascular, Inc.	2023	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	2	0
2011	1	0
2013	1	0
2015	1	0
2018	2	0
2020	2	0
2021	2	0
2022	1	0
2023	2	0
2024	6	0
2025	2	0
2026	4	0

FIG. 1 — Lineage of K011727, 2002–2026Source: 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 DRC? 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 DRC device

#1 K241042 SafeSharp Transseptal Needle (CLICK071…score 9.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

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	Recalls
*	—	Cook, Transseptal Needle Named without a submission number	—
*	—	Daig, Transseptal Needle Named without a submission number	—
*	—	C.R. Bard, USCI® Brockenbrough® Needles and Accessories Named without a submission number	—

What descends from it? (28)

See all 28

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

Number	Device	Applicant	Decided	Descendants
K073326	NRG Transseptal Needle	Baylis Medical Co., Inc.	2008	16
K072278	BRK Transseptal Needle	St Jude Medical	2007	8
K061070	Hansen Medical Transseptal Needle and Dilator	Hansen Medical, Inc.	2006	1
K111644	Mobicath Transseptal Needle	Great Batch Medical	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 15, 2016	Class II	Z-1375-2016	Software design	Merit Medical Systems, Inc. is voluntarily conducting a recall of one lot of the TSX" Transseptal Needle due to a discrepancy between the labeling and the actual configuration of the device in the packaging. The curve dimensional values…

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K073326 (Baylis Medical Co., Inc., 2008) has gone furthest, with 16 descendants of its own.

How does its category compare?

All DRC devices

DRC Trocar: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DRC

2in 2024

2007high 2 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DRC

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

Recalls per year · DRC

1in 2021

2007high 1 (2009) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · DRC

69in 2025

2007high 109 (2023) · low 2 (2008)2025

MAUDE reports naming product code DRC, 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	1	—	0	106
2008	1	—	0	2
2009	0	—	1	17
2010	0	—	1	33
2011	1	—	0	68
2012	1	—	0	58
2013	1	—	1	37
2014	2	—	1	65
2015	0	—	0	52
2016	0	—	0	62
2017	2	—	0	70
2018	2	—	0	85
2019	0	—	1 (1)	95
2020	0	—	0	108
2021	1	—	1	78
2022	2	—	0	61
2023	0	—	0	109
2024	2	—	0	105
2025	0	—	0	69
2026	0	—	0	—

What is it indicated for?

Used to create the primary puncture in the interatrial septum when passing an introducer and/or catheter through the septum from the right side of the heart to the left side.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011727 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011727: Transseptal Needle/Trocar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011727

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026