# K953676: Breeze Digital Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Namic
- Decided: Mar 29, 1996 after 235 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: 1 generation back to K904275 (1991). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904275: Morse Balloon Inflation Device, North American Instrument Corp. (1991) Summary page 2.
- (no number) Merit Monarch Inflation Syringe: named in the summary without a submission number

## Most influential descendants
- K022061: Cvsi Peripheral Balloon Catheter; Cvsi Inflater (2002), 9 descendants of its own
- K040155: Peripheral Cutting Balloon (2004), 6 descendants of its own
- K051254: Peripheral Cutting Balloon (2005), 5 descendants of its own
- K041993: 2 CM Peripheral Cutting Baloon (2004), 5 descendants of its own
- K052038: Peripheral Cutting Balloon Small Monorail or Over-the-Wire Delivery System (2005), 4 descendants of its own

## Indications for use
These devices are intended for balloon inflation/deflation and to measure the pressure within the balloon during angioplasty procedures.

Source page: https://510kreport.com/device/K953676
Methodology: https://510kreport.com/methodology