510(k) · Cleared

Cleared

Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10

K012489510(k) SpecialCleared Aug 30, 200127-day reviewClass II21 CFR 870.1340

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

Appriva Medical, Inc. · DYB Introducer, Catheter

Cleared on Aug 30, 2001 as substantially equivalent to K002054 (Appriva Medical, Inc., 2001) after a 27-day review. Its family tree reaches back 1 generation to 2001. 10 later devices descend from it.

Decided: Aug 30, 2001
Review: 27 days
Class: Class II
Product code: DYB
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002054 (2001). 10 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002054 X-Sept Transseptal Sheath and Transition Catheter, Model…Appriva Medical, Inc. · 2001
This deviceK012489 Modification to: X-Sept Transseptal Shealth and Transition Catheter…Appriva Medical, Inc. · 2001
Descendant · cites it directly · 9 of its ownK043084 Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005
Descendant · 2 generations on · 8 of its ownK083793 Steerable Guide CatheterEvalve, Inc. · 2009
Descendant · 3 generations on · 7 of its ownK091596 Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009
Descendant · 3 generations on · 6 of its ownK093866 Evalve Steerable Guide CatheterEvalve, Inc. · 2010
Descendant · 3 generations on · 5 of its ownK100789 Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2005high 2 (2009) · low 0 (2006)2026

Most influential descendants

Showing 5 of 10 · See all

K043084Premere Delivery Sheath, Model PDSVelocimed, Inc. · 2005 · cites it directly9descendants
K083793Steerable Guide CatheterEvalve, Inc. · 2009 · 2 generations on8descendants
K091596Evalve Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2009 · 3 generations on7descendants
K093866Evalve Steerable Guide CatheterEvalve, Inc. · 2010 · 3 generations on6descendants
K100789Modificaton to: Steerable Guide Catheter, Model SGC01STEvalve, Inc. · 2010 · 3 generations on5descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002054	X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90…	Appriva Medical, Inc.	2001	—
0 (this device)	K012489	Modification to: X-Sept Transseptal Shealth and Transition Catheter (with…	Appriva Medical, Inc.	2001	—
+1	K043084	Premere Delivery Sheath, Model PDS	Velocimed, Inc.	2005	—
+2	K083793	Steerable Guide Catheter	Evalve, Inc.	2009	—
+3	K091596	Evalve Steerable Guide Catheter, Model SGC01ST	Evalve, Inc.	2009	—
+3	K093866	Evalve Steerable Guide Catheter	Evalve, Inc.	2010	—
+3	K100789	Modificaton to: Steerable Guide Catheter, Model SGC01ST	Evalve, Inc.	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2009	2	0
2010	2	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2016	1	0

FIG. 1 — Lineage of K012489, 2001–2016Source: 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 DYB? 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 DYB device

#1 K251051 AuST Steerable Sheathscore 18.0 · 10 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? (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
*	K002054	X-Sept Transseptal Sheath and Transition Catheter, Model MV-03-09-90, MV-03-10-90… Summary page 1 …uestions raised regarding safety or efficacy of the device. Identification of Predicate Device Manufacturer and Device Name 510(k) Number Apptiva Medical, Inc., X-Sept K002054 Transseptal Sheath and Transition Catheter (with Dilator) Compliance with Performance None are established under Section 514, M…	Appriva Medical, Inc.	2001	—

Also cleared against K002054: 1 other device →

What descends from it? (10)

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

Number	Device	Applicant	Decided	Descendants
K043084	Premere Delivery Sheath, Model PDS	Velocimed, Inc.	2005	9

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, K043084 (Velocimed, Inc., 2005) has gone furthest, with 9 descendants of its own.
1 other device also cites its predicate K002054.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DYB

16in 2025

2007high 30 (2014) · low 9 (2020)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DYB

63in 2025

2007high 156 (2018) · low 37 (2008)2026

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

Recalls per year · DYB

3in 2025

2007high 45 (2016) · low 1 (2018)2026

Class I (48 since 2007) Class II/III not classified

Adverse event reports per year · DYB

4,539in 2025

2007high 4,539 (2025) · low 316 (2007)2025

MAUDE reports naming product code DYB, 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	12	95	15	316
2008	17	37	9	423
2009	14	52	25	399
2010	18	123	18	445
2011	17	100	4	628
2012	22	128	3	898
2013	26	118	5 (1)	743
2014	30	122	2	780
2015	17	129	2 (1)	913
2016	19	95	45 (3)	1,234
2017	24	70	22 (1)	1,672
2018	19	156	1	1,903
2019	18	47	2	2,450
2020	9	49	21 (21)	2,465
2021	12	78	6	2,835
2022	13	143	2	4,084
2023	15	55	10	3,775
2024	18	56	2	3,931
2025	16	63	3	4,539
2026	17	59	23 (21)	—

What is it indicated for?

The X-Sept Transseptal Sheath and Transition Catheter is indicated for percutaneous introduction of various cardiovascular devices into the left side of the heart through the atrial septum.

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/K012489 · printed Nov 6, 2026

Cite this page

510(k) Report. “K012489: Modification to: X-Sept Transseptal Shealth and Transition Catheter (with Dilator), Models PL-12-12-09, PL-12-12-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012489

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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