510(k) · Cleared
ClearedDeflecting Ureteral Access Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · FED Endoscopic Access Overtube, Gastroenterology-Urology
Cleared on May 23, 2003 as substantially equivalent to K993650 (Applied Medical Resources, 1999) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- May 23, 2003
- Review
- 84 days
- Class
- Class II
- Product code
- FED
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990775 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
- 1 generation backK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
- This deviceK030642 Deflecting Ureteral Access SheathApplied Medical Resources Corp. · 2003
- Descendant · cites it directly · 0 of its ownK072521 Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K072521Cook Fiber Optic Bundle and Flexor Deflecting Access SheathCook Urological, Inc. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990775 | Ureteral Access Sheath Set | Applied Medical Resources | 1999 | — |
| −1 | K993650 | Ureteral Access Sheath Set - New Models | Applied Medical Resources | 1999 | — |
| 0 (this device) | K030642 | Deflecting Ureteral Access Sheath | Applied Medical Resources Corp. | 2003 | — |
| +1 | K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath | Cook Urological, Inc. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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? (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 |
|---|---|---|---|
| * | K993650 | Ureteral Access Sheath Set - New ModelsSummary page 1…doscope and Accessories, 21 CFR 876.1500 TRADE NAME: Not Determined PREDICATE DEVICES: Forte Ureteral Access Sheath Set (K993650 and K990775) Applied Medical Resources Corporation… | 1999 |
| * | K990775 | Ureteral Access Sheath SetSummary page 1…Accessories, 21 CFR 876.1500 TRADE NAME: Not Determined PREDICATE DEVICES: Forte Ureteral Access Sheath Set (K993650 and K990775) Applied Medical Resources Corporation Rancho Santa… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072521 | Cook Fiber Optic Bundle and Flexor Deflecting Access Sheath | 2007 | 0 |
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?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K072521 (Cook Urological, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993650.
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 Deflecting Ureteral Access Sheath is indicated for use in endoscopic urology procedures, facilitates the passage of endoscopes and other instruments through the urinary tract. The dilator may also be used to irrigate and aspirate fluids into the urinary tract and kidney.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030642 · printed Nov 3, 2026
Cite this page
510(k) Report. “K030642: Deflecting Ureteral Access Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030642
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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