510(k) · Cleared
ClearedAQ Hydrophilic Dilators
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · KOE Dilator, Urethral
Cleared on Oct 18, 1996 after a 155-day review. The FDA summary names its predicate without a number. 17 later devices descend from it.
- Decided
- Oct 18, 1996
- Review
- 155 days
- Class
- Class II
- Product code
- KOE
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 5 citing it directly.
- This deviceK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- Descendant · cites it directly · 6 of its ownK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- Descendant · 2 generations on · 5 of its ownK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · Recalled
- Descendant · cites it directly · 4 of its ownK043418 Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK172217 Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release…Cook Incorporated · 2017
- Descendant · 3 generations on · 2 of its ownK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K981611Snap-N-Peel IntroducersCircon Corp. · 1998 · cites it directly6descendants
- K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · 2 generations on5descendants
- K043418Cook Pediatric Flexor Ureteral Access ShealthCook Urological, Inc. · 2005 · cites it directly4descendants
- K172217Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access SheathCook Incorporated · 2017 · 2 generations on2descendants
- K120160Rocamed Rocaus PlatinumPromepla Sam · 2012 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| +1 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| +2 | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | 2 |
| +1 | K043418 | Cook Pediatric Flexor Ureteral Access Shealth | Cook Urological, Inc. | 2005 | 1 |
| +2 | K172217 | Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral… | Cook Incorporated | 2017 | — |
| +3 | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KOE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KOE device
- #1 K191061 Optilume Basic Urological Balloon Dilation…score -0.8 · 3 generations · no Class I recall
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Ureteral Dilators with Hydro Plus Named without a submission number | |
| * | — | Uncoated dilators Named without a submission number |
What descends from it? (17)
See all 175 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K981611 (Circon Corp., 1998) has gone furthest, with 6 descendants of its own.
How does its category compare?
All KOE devicesKOE Dilator, Urethral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KOE
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · KOE
Too few KOE 510(k)s in any year since 2007 to give a median.
Recalls per year · KOE
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KOE
11in 2025
MAUDE reports naming product code KOE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 9 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 23 |
| 2019 | 0 | — | 2 | 20 |
| 2020 | 1 | — | 0 | 23 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 15 |
| 2023 | 0 | — | 0 | 20 |
| 2024 | 0 | — | 0 | 22 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AQ Hydrophilic Dilators are intended to dilate the suprapubic and/or nephrostomy fascial tract, urethra and ureters.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K961904 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961904: AQ Hydrophilic Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961904
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026