510(k) · Cleared
Recalled · Class II · 2017Scimed Encore 26 Inflation Device/Encore 30 Inflation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scimed Life Systems, Inc. · MAV Syringe, Balloon Inflation
Cleared on Mar 22, 1996 after an 87-day review. The FDA summary names its predicate without a number. 9 later devices descend from it. It has been recalled once.
- Decided
- Mar 22, 1996
- Review
- 87 days
- Class
- Class II
- Product code
- MAV
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK955869 Scimed Encore 26 Inflation Device/Encore 30 Inflation DeviceScimed Life Systems, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK032840 Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004
- Descendant · 2 generations on · 1 of its ownK103231 Kyphon Inflation SyringeMedtronic Spine, LLC · 2011
- Descendant · 2 generations on · 0 of its ownK181713 Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018
- Descendant · 2 generations on · 0 of its ownK140943 Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015
- Descendant · cites it directly · 0 of its ownK143522 Presto Inflation DeviceC.R. Bard, Inc. · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K032840Atrion Medical QL Inflation DeviceAtrion Medical Products, Inc. · 2004 · cites it directly6descendants
- K103231Kyphon Inflation SyringeMedtronic Spine, LLC · 2011 · 2 generations on1descendant
- K181713Ultraxx Nephrostomy Balloon Catheter SetCook Incorporated · 2018 · 2 generations on0descendants
- K140943Mastro Plus Balloon in-Deflation DeviceBeijing Demax Medical Technology Co.,Ltd · 2015 · 2 generations on0descendants
- K143522Presto Inflation DeviceC.R. Bard, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955869 | Scimed Encore 26 Inflation Device/Encore 30 Inflation Device | Scimed Life Systems, Inc. | 1996 | — |
| +1 | K032840 | Atrion Medical QL Inflation Device | Atrion Medical Products, Inc. | 2004 | — |
| +2 | K103231 | Kyphon Inflation Syringe | Medtronic Spine, LLC | 2011 | — |
| +2 | K181713 | Ultraxx Nephrostomy Balloon Catheter Set | Cook Incorporated | 2018 | — |
| +2 | K140943 | Mastro Plus Balloon in-Deflation Device | Beijing Demax Medical Technology Co.,Ltd | 2015 | — |
| +1 | K143522 | Presto Inflation Device | C.R. Bard, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 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? (5)
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 |
|---|---|---|---|
| * | — | SCIMED Encore Inflation Device Named without a submission number | |
| * | — | Merit® Monarch™ Inflation Device Named without a submission number | |
| * | — | Cordis® Reusable Inflation Devices Named without a submission number | |
| * | — | SCIMED Encore™ Advantage Kits Named without a submission number | |
| * | — | ACS® 20720 Priority Pack Named without a submission number |
What descends from it? (9)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 15, 2017 | Class II | Z-3043-2017 | Under Investigation by firm | Boston Scientific (BSC) has received complaints for cracked trays on the Encore device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K032840 (Atrion Medical Products, Inc., 2004) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MAV devicesMAV Syringe, Balloon Inflation: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 and Encore 30 Inflation Devices are intended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.
The Encore 26 and Encore 30 Advantage Kits are accessories used for general intravascular procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K955869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955869: Scimed Encore 26 Inflation Device/Encore 30 Inflation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955869
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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