# K122152: Oxti Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Oxti Corporation
- Decided: Dec 14, 2012 after 147 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 K854261 (1985). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042449: Dolphin Inflation Device, Sedat S.A. (2005) Summary page 1.
- K962495: Indeflator Plus 30/Plus 30 Priority PACK9WITH the.096 or.115 Rotating Hemostatic Valve), Advanced Cardiovascular Systems, Inc. (1996) Summary page 1.

## Indications for use
The OXTI Inflation Device is indicated for use during cardiovascular procedures to create, maintain, and monitor pressure in the balloon dilation catheter.

Source page: https://510kreport.com/device/K122152
Methodology: https://510kreport.com/methodology