510(k) · Cleared

Recalled · Class I · 2020

transGlideXT Expandable Introducer

K181817510(k) TraditionalCleared Mar 26, 2019260-day reviewClass II21 CFR 870.1340Recalls 1 (1 Class I)

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

Transaortic Medical, Inc. · DYB Introducer, Catheter

Cleared on Mar 26, 2019 as substantially equivalent to K152194 (Transaortic Medical, Inc., 2016) after a 260-day review. Its family tree reaches back 3 generations to 2009. 2 of the 4 devices in its family, counting itself, have a Class I recall. It has been recalled once, including a Class I recall.

Decided: Mar 26, 2019
Review: 260 days
Class: Class II
Product code: DYB
Recalls: 1 (1 Class I)
Predicates: 1

Its longest line of descent runs back 3 generations to K092014 (2009). No later device cites it as a predicate yet. 2 of the 4 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 3 generations backK092014 Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2009
2 generations backK100819 The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · Recalled (Class I)
1 generation backK152194 transGlide Expandable IntroducerTransaortic Medical, Inc. · 2016
This deviceK181817 transGlideXT Expandable IntroducerTransaortic Medical, Inc. · 2019

Class I recalls in this family

K100819 The Solopath Balloon Expandable Transfemoral…2 generations back · 2010

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K092014	Solopath Balloon Expandable Transfemoral Introducer	Onset Medical Corporation	2009	—
−2	K100819	The Solopath Balloon Expandable Transfemoral Introducer	Onset Medical Corporation	2010	Class I
−1	K152194	transGlide Expandable Introducer	Transaortic Medical, Inc.	2016	—
0 (this device)	K181817	transGlideXT Expandable Introducer	Transaortic Medical, Inc.	2019	—

FIG. 1 — Lineage of K181817, 2009–2019Source: 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.

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 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

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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
*	K152194	transGlide Expandable Introducer Summary page 5 …Page 2 of 5 III. PREDICATE TransAortic Medical, Inc. transGlide Expandable Introducer (K152194) This predicate has not been subject to a design-related recall. No reference devices were used in this submission.…	Transaortic Medical, Inc.	2016	—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
May 12, 2020	Class I	Z-2039-2020	Process control	Increased risk of events associated with vascular complications (bleeding, hematoma, and dissection)

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.

K100819The Solopath Balloon Expandable Transfemoral IntroducerOnset Medical Corporation · 2010 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
1 of the 3 ancestors has a recall of any class; 1 has a Class I recall.

How does its category compare?

All DYB devices

DYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.

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 transGlideXT Expandable Introducer is intended to be inserted into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and/or devices introduced into the femoral iliac arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K181817 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181817: transGlideXT Expandable Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181817

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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