# K961904: AQ Hydrophilic Dilators

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: Oct 18, 1996 after 155 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
No predicates in its family tree.
17 later devices descend from it; 5 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ureteral Dilators with Hydro Plus: named in the summary without a submission number
- (no number) Uncoated dilators: named in the summary without a submission number

## Most influential descendants
- K981611: Snap-N-Peel Introducers (1998), 6 descendants of its own
- K051593: Uropass Ureteral Access Sheath, Model 61224 (2005), 5 descendants of its own
- K043418: Cook Pediatric Flexor Ureteral Access Shealth (2005), 4 descendants of its own
- K172217: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath (2017), 2 descendants of its own
- K120160: Rocamed Rocaus Platinum (2012), 2 descendants of its own

## Indications for use
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nephrostomy fascial tract, urethra and ureters.

Source page: https://510kreport.com/device/K961904
Methodology: https://510kreport.com/methodology