510(k) · Decided
Recalled · Class II · 2025Encore 26 Advantage Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corp · MAV Syringe, Balloon Inflation
Cleared on Apr 17, 2014 as substantially equivalent to K123214 (Boston Scientific Corp, 2012) and 1 other predicate after a 23-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.
- Decided
- Apr 17, 2014
- Review
- 23 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K951802 (1995). 4 ancestors in all, the oldest K922410 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK951802 Scimed Encore Advantage Kit and the Essentials KitScimed Life Systems, Inc. · 1995
- 2 generations backK120694 Encore 26 Advantage KitBoston Scientific Corp · 2012
- 1 generation backK123214 Encore 26 Advantage KitBoston Scientific Corp · 2012
- This deviceK140745 Encore 26 Advantage KitBoston Scientific Corp · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K951802 | Scimed Encore Advantage Kit and the Essentials Kit | Scimed Life Systems, Inc. | 1995 | — |
| −2 | K120694 | Encore 26 Advantage Kit | Boston Scientific Corp | 2012 | — |
| −1 | K123214 | Encore 26 Advantage Kit | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K140745 | Encore 26 Advantage Kit | Boston Scientific Corp | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 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.
Planning a device in MAV? 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 MAV device
- #1 K260035 Digital Indeflator INFLANTEscore 12.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K123214 | Encore 26 Advantage KitSummary page 1…ringe, Balloon Inflation Classification Class 11,21 CFR Part 870.1650 - Cardiovascular Predicate Device(s) Encore TM 26 Advantage Kit K123214 Nov 13, 2012 SCIMED AVENUE Coronary K922410 Jul 23, 1992… | 2012 |
| * | K922410 | Scimed Avenue Coronary Guidewire Insertion ToolSummary page 1…vascular Predicate Device(s) Encore TM 26 Advantage Kit K123214 Nov 13, 2012 SCIMED AVENUE Coronary K922410 Jul 23, 1992 Guidewire Insertion Tool Device Description The Encore'"M 26 Ad… | 1992 |
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 |
|---|---|---|---|---|
| Aug 5, 2025 | Class II | Z-2534-2025 | Under Investigation by firm | The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K123214.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MAV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MAV
69in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAV
4in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAV
66in 2025
MAUDE reports naming product code MAV, 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 | 0 | — | 0 | 37 |
| 2008 | 1 | — | 0 | 50 |
| 2009 | 0 | — | 0 | 99 |
| 2010 | 0 | — | 3 | 88 |
| 2011 | 1 | — | 0 | 94 |
| 2012 | 4 | 85 | 0 | 251 |
| 2013 | 1 | — | 0 | 245 |
| 2014 | 2 | — | 2 | 92 |
| 2015 | 3 | 116 | 0 | 121 |
| 2016 | 3 | 69 | 1 | 124 |
| 2017 | 0 | — | 0 | 246 |
| 2018 | 0 | — | 1 | 300 |
| 2019 | 0 | — | 0 | 199 |
| 2020 | 0 | — | 0 | 101 |
| 2021 | 0 | — | 0 | 186 |
| 2022 | 1 | — | 5 | 437 |
| 2023 | 0 | — | 0 | 220 |
| 2024 | 0 | — | 4 | 420 |
| 2025 | 0 | — | 0 | 66 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Encore 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control. *Encore 26 Inflation Device: indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon. *Gateway Plus Y-Adaptor: used for providing hemostasis around balloon dilatation catheters…
Read the full statement (99 words)
The Encore 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control.
*Encore 26 Inflation Device: indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
*Gateway Plus Y-Adaptor: used for providing hemostasis around balloon dilatation catheters, guidewires and other therapeutic devices during general intravascular procedures.
*Torque Device: used for guidewire manipulation during general intravascular procedures.
*Insertion Tool: used to facilitate the introduction of a guidewire during general intravascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140745 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140745: Encore 26 Advantage Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140745
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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