# K955869: Scimed Encore 26 Inflation Device/Encore 30 Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Scimed Life Systems, Inc.
- Decided: Mar 22, 1996 after 87 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SCIMED Encore Inflation Device: named in the summary without a submission number
- (no number) Merit® Monarch™ Inflation Device: named in the summary without a submission number
- (no number) Cordis® Reusable Inflation Devices: named in the summary without a submission number
- (no number) SCIMED Encore™ Advantage Kits: named in the summary without a submission number
- (no number) ACS® 20720 Priority Pack: named in the summary without a submission number

## Most influential descendants
- K032840: Atrion Medical QL Inflation Device (2004), 6 descendants of its own
- K103231: Kyphon Inflation Syringe (2011), 1 descendant of its own
- K181713: Ultraxx Nephrostomy Balloon Catheter Set (2018), 0 descendants of its own
- K140943: Mastro Plus Balloon in-Deflation Device (2015), 0 descendants of its own
- K143522: Presto Inflation Device (2015), 0 descendants of its own

## Recalls of this device
- Jun 15, 2017 · Class II · Z-3043-2017: Boston Scientific (BSC) has received complaints for cracked trays on the Encore device.

## Indications for use
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.

Source page: https://510kreport.com/device/K955869
Methodology: https://510kreport.com/methodology