# K962611: Bard Eagle Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Ryder Intl. Corp.
- Decided: Oct 21, 1996 after 110 days
- Product code: KOE (Dilator, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5520
- 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 K953522 (1996). 1 ancestor in all.
12 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953522: Usci Ideal Ptca Kit, Ryder Intl. Corp. (1996) Summary page 1.

## Most influential descendants
- K972964: Atrion Medical Balloon Catheter Inflation Device (1997), 11 descendants of its own
- K032840: Atrion Medical QL Inflation Device (2004), 6 descendants of its own
- K020333: Atrion Medical QL Fluid Dispensing Syringe (2002), 2 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

## Indications for use
The inflation device is intended for single use while performing urological balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

Source page: https://510kreport.com/device/K962611
Methodology: https://510kreport.com/methodology