510(k) · Cleared
ClearedEncore 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 Nov 13, 2012 as substantially equivalent to K120694 (Boston Scientific Corp, 2012) after a 29-day review. Its family tree reaches back 2 generations to 1995. 3 later devices descend from it.
- Decided
- Nov 13, 2012
- Review
- 29 days
- Class
- Class II
- Product code
- MAV
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K951802 (1995). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK951802 Scimed Encore Advantage Kit and the Essentials KitScimed Life Systems, Inc. · 1995
- 1 generation backK120694 Encore 26 Advantage KitBoston Scientific Corp · 2012
- This deviceK123214 Encore 26 Advantage KitBoston Scientific Corp · 2012
- Descendant · cites it directly · 1 of its ownK140673 Insertion ToolBoston Scientific Corp · 2014
- Descendant · 2 generations on · 0 of its ownK172453 WATCHDOG Hemostasis Valve KitBoston Scientific Corporation · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK140745 Encore 26 Advantage KitBoston Scientific Corp · 2014 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951802 | Scimed Encore Advantage Kit and the Essentials Kit | Scimed Life Systems, Inc. | 1995 | — |
| −1 | K120694 | Encore 26 Advantage Kit | Boston Scientific Corp | 2012 | — |
| 0 (this device) | K123214 | Encore 26 Advantage Kit | Boston Scientific Corp | 2012 | — |
| +1 | K140673 | Insertion Tool | Boston Scientific Corp | 2014 | — |
| +2 | K172453 | WATCHDOG Hemostasis Valve Kit | Boston Scientific Corporation | 2017 | 2 |
| +1 | K140745 | Encore 26 Advantage Kit | Boston Scientific Corp | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K120694 | Encore 26 Advantage KitSummary page 1…torque device Classification: 11 Product Code: MAV 21 CFR 870.1650 Predicate Device: Encore TM 26 Advantage Kit (K120694, 03 April 2012). Device Description: The EncoreTM Advantage Kit is a kit of sterile disposable devices intended for use as access… | 2012 |
| † | K123024 | Torque Device | 2012 |
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? (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 17 years and passes through 2 companies; a new generation was cleared every 16.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K140673 (Boston Scientific Corp, 2014) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K120694.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 EncoreTM 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. Individual Device Intended Use: * EncoreTM 26 Inflation Device: Inflation device are indicated for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. * GateWay TM Plus Y-Adapter: Used for…
Read the full statement (107 words)
The EncoreTM 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.
Individual Device Intended Use:
* EncoreTM 26 Inflation Device: Inflation device are indicated for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
* GateWay TM Plus Y-Adapter: Used for providing hemostasis around guidewires, balloon dilatation catheters, and other therapeutic devices
* Torque Device: Used for guidewire manipulation during general intravascular procedures.
* Guidewire Insertion Tool: Used for percutaneous introduction and placement of guidewires in vascular procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123214 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123214: 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/K123214
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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