510(k) · Cleared
Recalled · Class II · 2024Uropass Ureteral Access Sheath, Model 61224
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acmi Corporation · KNY Accessories, Catheter, G-U
Cleared on Sep 2, 2005 as substantially equivalent to K981611 (Circon Corp., 1998) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1996. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 2, 2005
- Review
- 78 days
- Class
- Class II
- Product code
- KNY
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K961904 (1996). 5 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
- 1 generation backK981611 Snap-N-Peel IntroducersCircon Corp. · 1998
- This deviceK051593 Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005
- Descendant · cites it directly · 2 of its ownK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
- Descendant · 2 generations on · 1 of its ownK140441 BI-Flex Ureteral Access SheathPromepla Sam · 2014
- Descendant · cites it directly · 1 of its ownK123170 Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America · 2013
- Descendant · 2 generations on · 0 of its ownK182403 Peel-Away IntroducerCook Incorporated · 2019
- Descendant · 3 generations on · 0 of its ownK182144 Bi-Flex EvoPromepla Sam · 2018
Most influential descendants
Showing 5 of 5 · See all- K120160Rocamed Rocaus PlatinumPromepla Sam · 2012 · cites it directly2descendants
- K140441BI-Flex Ureteral Access SheathPromepla Sam · 2014 · 2 generations on1descendant
- K123170Vari-Pass Variable Length Access SheathOlympus Surgical Technologies America · 2013 · cites it directly1descendant
- K182403Peel-Away IntroducerCook Incorporated · 2019 · 2 generations on0descendants
- K182144Bi-Flex EvoPromepla Sam · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961904 | AQ Hydrophilic Dilators | Cook Urological, Inc. | 1996 | — |
| −1 | K981611 | Snap-N-Peel Introducers | Circon Corp. | 1998 | — |
| 0 (this device) | K051593 | Uropass Ureteral Access Sheath, Model 61224 | Acmi Corporation | 2005 | — |
| +1 | K120160 | Rocamed Rocaus Platinum | Promepla Sam | 2012 | — |
| +2 | K140441 | BI-Flex Ureteral Access Sheath | Promepla Sam | 2014 | — |
| +1 | K123170 | Vari-Pass Variable Length Access Sheath | Olympus Surgical Technologies America | 2013 | — |
| +2 | K182403 | Peel-Away Introducer | Cook Incorporated | 2019 | — |
| +3 | K182144 | Bi-Flex Evo | Promepla Sam | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 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 KNY? 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 KNY device
- #1 K260919 Transurethral Catheter Safety Valve (TUCSV)…score 11.8 · 1 generation · 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 |
|---|---|---|---|
| * | K981611 | Snap-N-Peel IntroducersSummary page 1…Urological catheter and accessories Predicate Device(s): Snap-N-PeeFTM Introducer K981611 Applied Medical Ureteral Access Sheath… | 1998 |
| * | K993650 | Ureteral Access Sheath Set - New ModelsSummary page 1…K981611 Applied Medical Ureteral Access Sheath K993650 Description of the Device: The UroPass Access Sheath is a single use, sterile (EtO sterilized) disposable product. The sheath is… | 1999 |
What descends from it? (5)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2024 | Class II | Z-0364-2025 | Storage | Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures. |
| May 19, 2023 | Class II | Z-2401-2023 | Nonconforming Material/Component | Dilator tips may break in the package and in patients during surgical procedures. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K120160 (Promepla Sam, 2012) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K981611.
How does its category compare?
All KNY devicesKNY Accessories, Catheter, G-U: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KNY
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KNY
103in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNY
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNY
3in 2025
MAUDE reports naming product code KNY, 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 | 15 |
| 2008 | 0 | — | 0 | 19 |
| 2009 | 1 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 1 | 6 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 3 | 103 | 0 | 7 |
| 2015 | 0 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 1 | — | 0 | 21 |
| 2018 | 1 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 19 |
| 2020 | 0 | — | 0 | 36 |
| 2021 | 0 | — | 0 | 17 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 1 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Intended to be a conduit for the passage of endoscopes and other urological
devices for the purpose of performing diagnostic and surgical procedures, such
as, nephrostomy, cystoscopy, or ureteroscopy, in the urinary tract.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051593 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051593: Uropass Ureteral Access Sheath, Model 61224.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051593
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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