510(k) · Cleared
Recalled · 2011Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thomas Medical Products, Inc. · DYB Introducer, Catheter
Cleared on Apr 10, 2001 after a 127-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 114 devices in its family, counting itself, have a Class I recall. 113 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 10, 2001
- Review
- 127 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 6
- Predicates
- 0
113 later devices descend from it, 9 citing it directly. 5 of the 114 devices in this family, counting this one, have a Class I recall.
- This deviceK003731 Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveThomas Medical Products, Inc. · 2001
- Descendant · cites it directly · 97 of its ownK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
- Descendant · cites it directly · 89 of its ownK012083 Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001
- Descendant · cites it directly · 80 of its ownK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
- Descendant · 2 generations on · 37 of its ownK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
- Descendant · 2 generations on · 35 of its ownK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 113 · See all- K012130Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001 · cites it directly97descendants
- K012083Attain Access 6218 Left-Heart Delivery System, Model 6218Medtronic Vascular · 2001 · cites it directly89descendants
- K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002 · cites it directly80descendants
- K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003 · 2 generations on37descendants
- K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management · 2004 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve | Thomas Medical Products, Inc. | 2001 | — |
| +1 | K012130 | Attain LDS 6216 Left-Heart Delivery System | Medtronic Vascular | 2001 | — |
| +1 | K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | Medtronic Vascular | 2001 | — |
| +1 | K013517 | 10600 Deflectable Catheter System, Model 10600 | Medtronic Vascular | 2002 | — |
| +2 | K032312 | Attain 6226DEF Deflectable Catheter Delivery System | Medtronic Vascular | 2003 | — |
| +2 | K033989 | Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 | Medtronic Inc. Cardiac Rhythm Management | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 14 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 6 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 1 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 1 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 1 |
| 2022 | 2 | 1 |
| 2023 | 3 | 0 |
| 2024 | 5 | 1 |
| 2025 | 7 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
5 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (113)
See all 1139 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012130 | Attain LDS 6216 Left-Heart Delivery System | 2001 | 97 |
| K012083 | Attain Access 6218 Left-Heart Delivery System, Model 6218 | 2001 | 89 |
| K013517 | 10600 Deflectable Catheter System, Model 10600 | 2002 | 80 |
| K053400 | Acumen Single-Lumen Delivery Sheath | 2006 | 11 |
| K042376 | Acumen Sheath, Model TTW7807 | 2004 | 5 |
| K120158 | Coronary Sinus Guide and Lateral Vein Introducer Kits | 2012 | 3 |
| K063182 | Enpath Medical Viaseal Valved Peelable Introducer, Model 10866-XXX | 2006 | 2 |
| K050808 | Coronary Sinus Access Kit, Model KCS8F-01 | 2005 | 1 |
| K023937 | Cook Vascular Serpenta Coronary Sinus Introducer System | 2003 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 7, 2011 | Not classified | Z-0168-2012 | Nonconforming Material/Component | Radiopaque (RO)/soft tip of the braided core component in the CSG kits may detach from the braided core tube. |
| 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. |
| Dec 16, 2010 | Not classified | Z-1227-2011 | Packaging process control | Compromised sterility/weak or open seals. |
| Dec 17, 2009 | Not classified | Z-0661-2010 | Component design/selection | Radiopaque sheath tip may fracture |
| Sep 12, 2008 | Not classified | Z-0131-2009 | Process control | Difficulty inserting guidewire through introducer needle. Needle hub is not tapered down to the needle cannula. |
The 5 latest of 6 recalls; the web page lists all.
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.
- K121611Amplatzer Torqvue FXAga Medical Corporation · 2012 · 4 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K180864WATCHMAN TruSeal Access SystemBoston Scientific · 2018 · 5 generations on · ◆ in the 2018 descendants bar of FIG. 15 Class I recalls
- K212228WATCHMAN FXD Curve Access SystemBoston Scientific Corporation · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 13 Class I recalls
- K220340Amplatzer Steerable Delivery SheathAbbott Medical · 2022 · 7 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K240018WATCHMAN TruSteer Access System (M635TU90050)Boston Scientific Corporation · 2024 · 7 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K012130 (Medtronic Vascular, 2001) has gone furthest, with 97 descendants of its own.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DYB
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DYB
63in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DYB
3in 2025
Class I (48 since 2007) Class II/III not classified
Adverse event reports per year · DYB
4,539in 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) | — |
https://510kreport.com/device/K003731 · printed Nov 6, 2026
Cite this page
510(k) Report. “K003731: Safesheath MSP Introducer Sheath Kit with Integral Hemostasis Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003731
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026