510(k) · Cleared

Cleared

Pancreatic Drainage Tube

K021672510(k) TraditionalCleared Apr 16, 2003330-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

Aomori Olympus Co., Ltd. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Apr 16, 2003 as substantially equivalent to K933200 (Olympus Corp., 1995) and 1 other predicate after a 330-day review. Its family tree reaches back 1 generation to 1990.

Decided: Apr 16, 2003
Review: 330 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K900923 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK900923 Zimmon Endoscopic Pancreatic StentWilson-Cook Medical, Inc. · 1990
This deviceK021672 Pancreatic Drainage TubeAomori Olympus Co., Ltd. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K900923	Zimmon Endoscopic Pancreatic Stent	Wilson-Cook Medical, Inc.	1990	—
0 (this device)	K021672	Pancreatic Drainage Tube	Aomori Olympus Co., Ltd.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

FIG. 1 — Lineage of K021672, 1990–2003Source: 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

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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	Applicant	Decided	Recalls
*	K933200	Olympus PBD Stents Summary page 1 ….5010 Biliary catheter and accessories 21CFR #876.1500 Endoscope and accessories Predicate Device: Olympus PBD Stents #IC933200 Zimmon Endoscopic Pancreatic Stent (IC900923 Wilson-Cook Me…	Olympus Corp.	1995	4
*	K900923	Zimmon Endoscopic Pancreatic Stent Summary page 1 …Predicate Device: Olympus PBD Stents #IC933200 Zimmon Endoscopic Pancreatic Stent (IC900923 Wilson-Cook Medical, Inc.) KO2 16;’Z…	Wilson-Cook Medical, Inc.	1990	—

Also cleared against K933200: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

1 of the 2 ancestors has a recall of any class.
2 other devices also cite its predicate K933200.

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?

This instrument has been designed to be used with Olyinpus endoscopes for Endoscopic Pancreatic Drainage. The Drainage Tube is not intended to be permanently implanted in the patient. The Drainage Tube is intended for short-term implantation. The Drainage Tube is also available as a kit, which includes accessories to aid in the placement of the Drainage Tube.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021672 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021672: Pancreatic Drainage Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021672

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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