510(k) · Cleared

Recalled · 2010

Y-Glide

K072745510(k) SpecialCleared Jan 4, 200899-day reviewClass II21 CFR 870.4290Recalls 2

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. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Jan 4, 2008 as substantially equivalent to K991102 (Guidant Corp., 1999) after a 99-day review. Its family tree reaches back 2 generations to 1985. It has been recalled 2 times.

Decided: Jan 4, 2008
Review: 99 days
Class: Class II
Product code: DTL
Recalls: 2
Predicates: 1

Its longest line of descent runs back 2 generations to K854261 (1985). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK854261 Advanced Cardiovascular Systems Hemostatic ValvesAdvanced Cardiovascular Systems, Inc. · 1985 · Recalled
1 generation backK991102 Copilot Bleedback Control Valve, Model 1003331Guidant Corp. · 1999 · Recalled
This deviceK072745 Y-GlideThomas Medical Products, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K854261	Advanced Cardiovascular Systems Hemostatic Valves	Advanced Cardiovascular Systems, Inc.	1985	2
−1	K991102	Copilot Bleedback Control Valve, Model 1003331	Guidant Corp.	1999	1
0 (this device)	K072745	Y-Glide	Thomas Medical Products, Inc.	2008	—

FIG. 1 — Lineage of K072745, 1985–2008Source: 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 DTL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin 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
*	K991102	Copilot Bleedback Control Valve, Model 1003331 Summary page 1 …tic Wye Adapter C. Legally marketed device to which equivalence is claimed: Guidant [Abbott] CoPilot Bleedback Control Valve - K991102 D. Description of the device: The Thomas Medical Products Inc. Y-GlideTh Hemostatic Va…	Guidant Corp.	1999	1

Also cleared against K991102: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 16, 2010	Not classified	Z-1225-2011	Packaging process control	Compromised sterility/weak or open seals.
Dec 16, 2010	Not classified	Z-1228-2011	Packaging process control	Compromised sterility/weak or open seals.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
2 of the 2 ancestors have a recall of any class.
6 other devices also cite its predicate K991102.

How does its category compare?

All DTL devices

DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · DTL

1in 2015

2007high 8 (2012) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DTL

36in 2012

2007high 115 (2010) · low 36 (2012)2026

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

Recalls per year · DTL

1in 2025

2007high 3 (2010) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · DTL

110in 2025

2007high 452 (2024) · low 16 (2008)2025

MAUDE reports naming product code DTL, 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	37
2008	5	85	1	16
2009	2	—	0	62
2010	4	115	3	148
2011	0	—	1	160
2012	8	36	2	53
2013	1	—	1 (1)	67
2014	2	—	1	80
2015	1	—	0	89
2016	0	—	0	67
2017	0	—	2	106
2018	0	—	0	84
2019	0	—	0	76
2020	0	—	0	53
2021	0	—	0	55
2022	0	—	2	48
2023	0	—	0	46
2024	0	—	0	452
2025	0	—	1	110
2026	0	—	3 (3)	—

What is it indicated for?

The Y-GlideTM Hemostatic Wye Adapter is to be used for maintaining a hemostatic seal around inserted devices with an outside diameter up to 0.120" (3.04 mm) during the use of diagnostic/interventional devices for transluminal procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072745 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072745: Y-Glide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072745

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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