# K032840: Atrion Medical QL Inflation Device

- Pathway: 510(k) (Traditional)
- Applicant: Atrion Medical Products, Inc.
- Decided: Mar 3, 2004 after 174 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: 3 generations back to K953522 (1996). 4 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972964: Atrion Medical Balloon Catheter Inflation Device, Atrion Medical Products, Inc. (1997) Summary page 1.
- K962611: Bard Eagle Inflation Device, Ryder Intl. Corp. (1996) Summary page 1.
- K953522: Usci Ideal Ptca Kit, Ryder Intl. Corp. (1996) Summary page 1.
- K955869: Scimed Encore 26 Inflation Device/Encore 30 Inflation Device, Scimed Life Systems, Inc. (1996) Summary page 1.

## Most influential descendants
- K103231: Kyphon Inflation Syringe (2011), 1 descendant of its own
- K181713: Ultraxx Nephrostomy Balloon Catheter Set (2018), 0 descendants of its own
- K140943: Mastro Plus Balloon in-Deflation Device (2015), 0 descendants of its own
- K133795: Summed Inflation Device Kit (2014), 0 descendants of its own
- K113742: KMC Kyphoplasty System (2012), 0 descendants of its own

## Indications for use
The Inflation Device is recommended for use with balloon dilatation catheters to create and monitor the pressure in the balloon and to deflate the balloon.

Source page: https://510kreport.com/device/K032840
Methodology: https://510kreport.com/methodology