# K260035: Digital Indeflator INFLANTE

- Pathway: 510(k) (Traditional)
- Applicant: UAB Telemedicina
- Decided: Sep 4, 2026 after 241 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: 3 generations back to K943597 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160107: DiamondTOUCH Inflation Device and Fluid Dispensing Syringe, Merit Medical Systems, Inc. (2016) Summary page 5.

## Indications for use
Digital Indeflator INFLANTE is used to inflate and deflate balloon angioplasty catheters or other interventional devices and to measure the pressure and time of inflation within the balloon during the procedure. It is also used to control the dispensing of fluids through the catheter into the vascular system manually, while monitoring the remaining fluid volume. The system is intended to be used in conjunction with legally marketed 20 mL syringes validated as compatible with the INFLANTE system.

Source page: https://510kreport.com/device/K260035
Methodology: https://510kreport.com/methodology