# K133795: Summed Inflation Device Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
- Decided: Dec 12, 2014 after 364 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953522 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102648: Ant Inflation Device/Ant Inflation Device Compact Pack, Shenzhen Ant Hi-Tech Industrial Co., Ltd. (2011) Summary page 4.
- K032840: Atrion Medical QL Inflation Device, Atrion Medical Products, Inc. (2004) Summary page 4.

## Indications for use
The SunmedTM Inflation Device is a set of accessorial device. It is composed of an inflation device, and may be composed of a stopcock and a hemostatic valve. The inflation device is intended for use in PTCA or PTA procedures to create and monitor pressure (by connecting the rotating male luer of inflation device with the balloon catheter's female luer) in the balloon and to deflate the balloon. The hemostatic valve is recommended for use during PTCA or PTA procedures in conjunction and/or diagnostic device (e.g. balloon dilatation catheters).Stopcock is used to release and purge any trapped air (if used).

Source page: https://510kreport.com/device/K133795
Methodology: https://510kreport.com/methodology