510(k) · Cleared

Cleared

Ureteral Access Sheath Set - New Models

K993650510(k) TraditionalCleared Dec 28, 199960-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Medical Resources · FED Endoscopic Access Overtube, Gastroenterology-Urology

Cleared on Dec 28, 1999 as substantially equivalent to K990775 (Applied Medical Resources, 1999) after a 60-day review. Its family tree reaches back 1 generation to 1999. 11 later devices descend from it.

Decided: Dec 28, 1999
Review: 60 days
Class: Class II
Product code: FED
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K990775 (1999). 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK990775 Ureteral Access Sheath SetApplied Medical Resources · 1999
This deviceK993650 Ureteral Access Sheath Set - New ModelsApplied Medical Resources · 1999
Descendant · cites it directly · 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 · 2 generations on · 2 of its ownK120160 Rocamed Rocaus PlatinumPromepla Sam · 2012
Descendant · 3 generations on · 1 of its ownK140441 BI-Flex Ureteral Access SheathPromepla Sam · 2014

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2003high 2 (2005) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all

K051593Uropass Ureteral Access Sheath, Model 61224Acmi Corporation · 2005 · cites it directly5descendants
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 · 2 generations on2descendants
K140441BI-Flex Ureteral Access SheathPromepla Sam · 2014 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K990775	Ureteral Access Sheath Set	Applied Medical Resources	1999	—
0 (this device)	K993650	Ureteral Access Sheath Set - New Models	Applied Medical Resources	1999	—
+1	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	—
+2	K120160	Rocamed Rocaus Platinum	Promepla Sam	2012	—
+3	K140441	BI-Flex Ureteral Access Sheath	Promepla Sam	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
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

FIG. 1 — Lineage of K993650, 1999–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K990775	Ureteral Access Sheath Set Summary page 1 …s Sheath Set CLASSIFICATION NAME: Endoscope and Accessories, 21 CFR 876.1500 TRADE NAME: Not Determined PREDICATE DEVICES: 1. Applied Medical Ureteral Access Sheath Set (K990775) 2. Cook Urological’s Peel Away Introducer Sets. 3. Nottingham One-Step Tapered Dilators, Boston Scientific Corporation. INTENDE…	Applied Medical Resources	1999	—
*	—	Cook Urological’s Peel Away Introducer Sets Named without a submission number			—
*	—	Nottingham One-Step Tapered Dilators, Boston Scientific Corporation Named without a submission number			—

Also cleared against K990775: 2 other devices →

What descends from it? (11)

See all 11

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051593	Uropass Ureteral Access Sheath, Model 61224	Acmi Corporation	2005	5
K043418	Cook Pediatric Flexor Ureteral Access Shealth	Cook Urological, Inc.	2005	4
K030642	Deflecting Ureteral Access Sheath	Applied Medical Resources Corp.	2003	1

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?

Its one ancestor has no recall.
Of its descendants, K051593 (Acmi Corporation, 2005) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K990775.

How does its category compare?

All FED devices

FED Endoscopic Access Overtube, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FED

11in 2025

2007high 11 (2025) · low 1 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FED

120in 2025

2007high 189 (2021) · low 82 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FED

4in 2024

2007high 4 (2024) · low 0 (2008)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · FED

115in 2025

2007high 115 (2025) · low 14 (2007)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/K993650 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993650: Ureteral Access Sheath Set - New Models.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993650

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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