510(k) · Cleared
ClearedUreteral Access Sheath Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on Apr 21, 1999 after a 43-day review. The FDA summary names no predicate by number. 12 later devices descend from it.
- Decided
- Apr 21, 1999
- Review
- 43 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 3 citing it directly.
- This deviceK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
- Descendant · cites it directly · 11 of its ownK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
- 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 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K993650Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999 · cites it directly11descendants
- 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) | K990775 | Ureteral Access Sheath Set | Applied Medical Resources | 1999 | — |
| +1 | K993650 | Ureteral Access Sheath Set - New Models | Applied Medical Resources | 1999 | — |
| +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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 FED? 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 FED device
- #1 K241181 Disposable Ureteral Guide Sheathscore 15.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (12)
See all 123 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, K993650 (Applied Medical Resources, 1999) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FED devicesFED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FED
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FED
120in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FED
4in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · FED
115in 2025
MAUDE reports naming product code FED, 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 | 1 | — | 1 | 14 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 4 | 90 | 0 | 19 |
| 2010 | 3 | 90 | 0 | 19 |
| 2011 | 1 | — | 0 | 20 |
| 2012 | 4 | 82 | 0 | 35 |
| 2013 | 2 | — | 3 | 25 |
| 2014 | 4 | 123 | 0 | 34 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 5 | 126 | 0 | 29 |
| 2017 | 1 | — | 0 | 32 |
| 2018 | 4 | 122 | 0 | 34 |
| 2019 | 5 | 94 | 0 | 30 |
| 2020 | 4 | 117 | 0 | 33 |
| 2021 | 3 | 189 | 0 | 55 |
| 2022 | 1 | — | 0 | 36 |
| 2023 | 3 | 138 | 0 | 53 |
| 2024 | 6 | 98 | 4 (4) | 64 |
| 2025 | 11 | 120 | 0 | 115 |
| 2026 | 6 | 67 | 0 | — |
What is it indicated for?
The Ureteral Access Sheath Set is indicated for use in endoscopic urology procedures, by facilitating the passage of endoscopes and other instruments through the urinary tract.
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/K990775 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990775: Ureteral Access Sheath Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990775
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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