510(k) · Cleared

Cleared

Myshell

K040498510(k) TraditionalCleared Jul 2, 2004127-day reviewClass II21 CFR 870.4290

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

Sedat S.A. · DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Cleared on Jul 2, 2004 as substantially equivalent to K991102 (Guidant Corp., 1999) after a 127-day review. Its family tree reaches back 2 generations to 1985. 12 later devices descend from it.

Decided: Jul 2, 2004
Review: 127 days
Class: Class II
Product code: DTL
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K854261 (1985). 12 later devices descend from it, 4 citing it directly.

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 deviceK040498 MyshellSedat S.A. · 2004
Descendant · cites it directly · 5 of its ownK042449 Dolphin Inflation DeviceSedat S.A. · 2005 · Recalled
Descendant · 2 generations on · 3 of its ownK082755 Sedat FlamingoSedat · 2008 · Recalled
Descendant · cites it directly · 3 of its ownK072552 Merit Medical Systems, Inc., Guide Wire Torque DeviceMerit Medical Systems, Inc. · 2007
Descendant · 3 generations on · 1 of its ownK152387 Fluent Inflation DeviceVascular Solutions, Inc. · 2015
Descendant · 4 generations on · 0 of its ownK162272 Fluent inflation deviceVascular Solutions, Inc. · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2005high 2 (2008) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all

K042449Dolphin Inflation DeviceSedat S.A. · 2005 · cites it directly5descendants
K082755Sedat FlamingoSedat · 2008 · 2 generations on3descendants
K072552Merit Medical Systems, Inc., Guide Wire Torque DeviceMerit Medical Systems, Inc. · 2007 · cites it directly3descendants
K152387Fluent Inflation DeviceVascular Solutions, Inc. · 2015 · 3 generations on1descendant
K162272Fluent inflation deviceVascular Solutions, Inc. · 2016 · 4 generations on0descendants

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)	K040498	Myshell	Sedat S.A.	2004	—
+1	K042449	Dolphin Inflation Device	Sedat S.A.	2005	4
+2	K082755	Sedat Flamingo	Sedat	2008	1
+1	K072552	Merit Medical Systems, Inc., Guide Wire Torque Device	Merit Medical Systems, Inc.	2007	—
+3	K152387	Fluent Inflation Device	Vascular Solutions, Inc.	2015	—
+4	K162272	Fluent inflation device	Vascular Solutions, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2008	2	0
2010	2	0
2012	2	0
2013	1	0
2015	2	0
2016	1	0

FIG. 1 — Lineage of K040498, 1985–2016Source: 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 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 …al design and method of operation of the Copilotrm Bleedback Control Equivalence Valve manufactured by Guidant Corporation (K991 102). Device Description MYSHELL is an ergonomically designed y-connector/hemostatic valve…	Guidant Corp.	1999	1

Also cleared against K991102: 6 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K042449	Dolphin Inflation Device	Sedat S.A.	2005	5
K072552	Merit Medical Systems, Inc., Guide Wire Torque Device	Merit Medical Systems, Inc.	2007	3
K143252	Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)	Needle Tech Products, Inc.	2015	0
K080472	Sedat Myshell Lite	Sedat	2008	0

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?

The line of descent spans 19 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.
Of its descendants, K042449 (Sedat S.A., 2005) has gone furthest, with 5 descendants of its own.
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.

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?

MYSHELL and its accessories are indicated for assisting, manipulating and maintaining used a seal around diagnostic/interventional devices with an outside diameter <9F (.098") in interventional procedures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040498 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040498: Myshell.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040498

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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