510(k) · Cleared

Cleared

PBN Dilators

K990808510(k) TraditionalCleared Nov 26, 1999260-day reviewClass II21 CFR 876.5010

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

Medical Device Technologies, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Nov 26, 1999 as substantially equivalent to K961904 (Cook Urological, Inc., 1996) after a 260-day review. Its family tree reaches back 1 generation to 1996. 2 later devices descend from it.

Decided: Nov 26, 1999
Review: 260 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K961904 (1996). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK961904 AQ Hydrophilic DilatorsCook Urological, Inc. · 1996
This deviceK990808 PBN DilatorsMedical Device Technologies, Inc. · 1999
Descendant · cites it directly · 1 of its ownK183036 Dilator SetsCook Incorporated · 2018 · Recalled
Descendant · 2 generations on · 0 of its ownK210734 Endovascular Dilator and SetsCook Incorporated · 2021

Most influential descendants

Showing 2 of 2 · See all

K183036Dilator SetsCook Incorporated · 2018 · cites it directly1descendant
K210734Endovascular Dilator and SetsCook Incorporated · 2021 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K961904	AQ Hydrophilic Dilators	Cook Urological, Inc.	1996	—
0 (this device)	K990808	PBN Dilators	Medical Device Technologies, Inc.	1999	—
+1	K183036	Dilator Sets	Cook Incorporated	2018	3
+2	K210734	Endovascular Dilator and Sets	Cook Incorporated	2021	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2021	1	0

FIG. 1 — Lineage of K990808, 1996–2021Source: 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 FGE? 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 FGE device

#1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

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
*	K961904	AQ Hydrophilic Dilators Summary page 1 …870.1310 — Dilator, Vessel, for Percutaneous Catheterization SUBSTANTIAL EQUIVALENCE: Company Name Product Name 510(k) Ne. Cook Urological, Inc. AQ Hydrophilic Dilator K961904 DESCRIPTION OF DEVICE: The PBN Dilator is comprised of tubing that is either a hard or soft polyethylene and a hub that is made…	Cook Urological, Inc.	1996	—

Also cleared against K961904: 4 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K183036	Dilator Sets	Cook Incorporated	2018	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, K183036 (Cook Incorporated, 2018) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K961904.

How does its category compare?

All FGE devices

FGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGE

7in 2025

2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, 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	4	316	54	1,006
2008	11	214	93	1,465
2009	7	160	18	1,655
2010	9	81	32	1,434
2011	9	114	2	1,321
2012	8	96	4	1,183
2013	5	161	3	1,060
2014	8	156	0	1,270
2015	8	79	0	1,543
2016	4	49	0	1,453
2017	9	59	1	1,515
2018	7	215	43	1,681
2019	2	—	13	1,896
2020	4	121	1	2,182
2021	1	—	27	2,297
2022	6	101	21	1,749
2023	6	199	19	1,615
2024	6	188	1	1,948
2025	7	257	0	1,923
2026	8	153	11	—

What is it indicated for?

The PBN Dilators are intended for use in the introduction and placement of guidewires and catheters for biliary, nephrostomy, and general percutaneous fluid collection and drainage.

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/K990808 · printed Nov 4, 2026

Cite this page

510(k) Report. “K990808: PBN Dilators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990808

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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