510(k) · Cleared
Cleared5.5 F Worley Advanced LVI Lateral Vein Introducer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Systems, Inc. · DYB Introducer, Catheter
Cleared on Aug 27, 2015 as substantially equivalent to K120158 (Thomas Medical Products, Inc., 2012) after a 28-day review. Its family tree reaches back 3 generations to 2000. 1 of the 8 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Aug 27, 2015
- Review
- 28 days
- Class
- Class II
- Product code
- DYB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K000659 (2000). 6 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK000659 Modification to Softouch Diagnostic Intravascular CatMerit Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK053171 Merit Impress Diagnostic CatheterMerit Medical Systems, Inc. · 2006
- 1 generation backK120158 Coronary Sinus Guide and Lateral Vein Introducer KitsThomas Medical Products, Inc. · 2012 · Recalled
- This deviceK152116 5.5 F Worley Advanced LVI Lateral Vein IntroducerMerit Medical Systems, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK260459 VANES Delivery System (VDS)Zoll Respicardia, Inc. · 2026
Class I recalls in this family
- K001578 Angiodynamics Soft-VU Hydrophilic Coated…3 generations back · 2000
Most influential descendants
Showing 1 of 1 · See all- K260459VANES Delivery System (VDS)Zoll Respicardia, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000659 | Modification to Softouch Diagnostic Intravascular Cat | Merit Medical Systems, Inc. | 2000 | 1 |
| −2 | K053171 | Merit Impress Diagnostic Catheter | Merit Medical Systems, Inc. | 2006 | — |
| −1 | K120158 | Coronary Sinus Guide and Lateral Vein Introducer Kits | Thomas Medical Products, Inc. | 2012 | 2 |
| 0 (this device) | K152116 | 5.5 F Worley Advanced LVI Lateral Vein Introducer | Merit Medical Systems, Inc. | 2015 | — |
| +1 | K260459 | VANES Delivery System (VDS) | Zoll Respicardia, Inc. | 2026 | — |
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 |
|---|---|---|
| 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? (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 | Decided |
|---|---|---|---|
| * | K120158 | Coronary Sinus Guide and Lateral Vein Introducer KitsSummary page 4…Introducer Kits Classification Name: Introducer, Catheter (21 CFR §870.1340) Premarket Notification: K120158 Predicate Device Manufacturer: Merit Medical Systems, Inc.… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260459 | VANES Delivery System (VDS) | 2026 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- 4 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K260459 (Zoll Respicardia, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K120158.
How does its category compare?
All DYB devicesDYB Introducer, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to guide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5…
Read the full statement (132 words)
The 5.5 F Worley Advanced LVI Lateral Vein Introducer is intended to access the coronary venous system either alone or in a telescopic assembly with other devices. The 5.5 F Worley Advanced LVI Lateral Vein Introducer serve as a conduit to guide devices, including guidewires, pacemaker or defibrillator leads, and catheters, or to deliver contrast medium into specific branches of the coronary venous system. They have direct contact to the inner heart. 5.5 F Worley Advanced LVI Lateral Vein Introducers come with various curve configurations to facilitate sub-selective access to angulated lateral vein branches. 5.5 F Worley Advanced LVI Lateral Vein Introducers are designed as single use devices and for short term application (< 24 hours). Only medical doctors and medical personnel, who are well trained in cardiology, should apply these introducers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152116: 5.5 F Worley Advanced LVI Lateral Vein Introducer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152116
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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