510(k) · Cleared
Recalled · Class II · 2024Coronary Sinus Guide and Lateral Vein Introducer Kits
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 Aug 14, 2012 as substantially equivalent to K003731 (Thomas Medical Products, Inc., 2001) and 2 other predicates after a 209-day review. Its family tree reaches back 2 generations to 2000. 1 of the 9 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 14, 2012
- Review
- 209 days
- Class
- Class II
- Product code
- DYB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000659 (2000). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- This deviceK120158 Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012
- Descendant · cites it directly · 1 of its ownK152116 5.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK260459 VANES Delivery System (VDS)Zoll Respicardia, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK133501 Leadliner CS Lead Delivery SystemVascular Solutions, Inc. · 2014
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…2 generations back · 2000
Most influential descendants
Showing 3 of 3 · See all- K1521165.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc. · 2015 · cites it directly1descendant
- K260459VANES Delivery System (VDS)Zoll Respicardia, Inc. · 2026 · 2 generations on0descendants
- K133501Leadliner CS Lead Delivery SystemVascular Solutions, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| −1 | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| 0 (this device) | K120158 | Coronary Sinus Guide and Lateral Vein Introducer Kits | Thomas Medical Products, Inc. | 2012 | — |
| +1 | K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer | Merit Medical Systems, Inc. | 2015 | — |
| +2 | K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026 | — |
| +1 | K133501 | Leadliner CS Lead Delivery System | Vascular Solutions, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 1 |
| 2001 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2026 | 1 | 0 |
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.
1 device in this family has 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? (3)
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 | Decided |
|---|---|---|---|
| * | K003731 | Safesheath MSP Introducer Sheath Kit with Integral Hemostasis ValveSummary page 1…changes are: Element of Predicate device Modified Reason for modification modification k003731 device UIV Stabilization None 0.15- 0.20% Ta provide UV stabilization,… | 2001 |
| * | K053171 | Merit Impress Diagnostic CatheterSummary page 3…kits CSG kits - Catheter Lead k003731 k053171 Delivery Syste… | 2006 |
| * | K101776 | Scoutpro AcsSummary page 1…(b Merit Medical Systems, Inc. - Impress Radiology Catheter (1<053171) (c) Biatronik, Inc. -ScautPro ACS Coronary Sinus Lead Introducer System (1k101776) D. Description of changes: The reason far this submission is due to improvements made… | 2010 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 11, 2024 | Class II | Z-2571-2024 | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
| Jun 11, 2024 | Class II | Z-2577-2024 | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. |
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.
- K001578Angiodynamics Soft-VU Hydrophilic Coated Angiographic CatheterAngioDynamics, Inc. · 2000 · 2 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 3 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K152116 (Merit Medical Systems, Inc., 2015) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K003731.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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) | — |
What is it indicated for?
For the introduction of various types of pacing or defibrillator leads and catheters.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120158 · printed Nov 5, 2026
Cite this page
510(k) Report. “K120158: Coronary Sinus Guide and Lateral Vein Introducer Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K120158
Report an extraction error
Are you the manufacturer?
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