510(k) · Cleared

Cleared

Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter System

K973113510(k) TraditionalCleared Nov 10, 199782-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

Boston Scientific Corp · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Nov 10, 1997 as substantially equivalent to K934411 (Meadox Medicals, Div. Boston Scientific Corp., 1994) and 4 other predicates after an 82-day review. Its family tree reaches back 1 generation to 1985. 1 later device descends from it.

Decided: Nov 10, 1997
Review: 82 days
Class: Class II
Product code: FGE
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K851647 (1985). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK851647 Olbert Catheter System for Biliary Tract DilatatioMeadox Surgimed, Inc. · 1985
This deviceK973113 Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon…Boston Scientific Corp · 1997
Descendant · cites it directly · 0 of its ownK010714 Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420…Medi-Globe Corp. · 2003

Most influential descendants

Showing 1 of 1 · See all

K010714Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830Medi-Globe Corp. · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K851647	Olbert Catheter System for Biliary Tract Dilatatio	Meadox Surgimed, Inc.	1985	—
0 (this device)	K973113	Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter…	Boston Scientific Corp	1997	—
+1	K010714	Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830	Medi-Globe Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	2	0
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K973113, 1985–2003Source: 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

Get a 510(k) Report

What was it cleared against? (5)

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
*	K934411	Meadox Surgimed Olbert Catheter System Noprofile Summary page 3 …lber Balloon Catheler \| Vector TTS™ Balloon Bafloon Catheter i Modified End Connector Veclran Fibers for Biliary Dilatation Dilatation Catheter (This 510{k)) (510(k) No. K934411) (510(k) No. K945576) (510(k} No. K952867) (510(k) No. K851647) (510(k) No. K96 1438) USE .. Dilatation of Biliary and Dilatation…	Meadox Medicals, Div. Boston Scientific Corp.	1994	—
*	K945576	Meadox Surgimed Noprofile (TM) Olbert Catheter System (R) Summary page 3 …\| Vector TTS™ Balloon Bafloon Catheter i Modified End Connector Veclran Fibers for Biliary Dilatation Dilatation Catheter (This 510{k)) (510(k) No. K934411) (510(k) No. K945576) (510(k} No. K952867) (510(k) No. K851647) (510(k) No. K96 1438) USE .. Dilatation of Biliary and Dilatation of Gl Indication Oth…	Meadox Medicals, Div. Boston Scientific Corp.	1995	—
*	K952887	Noprofile Olbert Catheter System Balloon Dilatation Catheter Our OCR of the scanned summary read K952867, FDA’s number for Remanium:GM 700, GM 380, GM 800, GFH (Dentauraum, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “NoProfile®”.	Meadox Medicals, Div. Boston Scientific Corp.	1995	—
*	K851647	Olbert Catheter System for Biliary Tract Dilatatio Summary page 3 …Modified End Connector Veclran Fibers for Biliary Dilatation Dilatation Catheter (This 510{k)) (510(k) No. K934411) (510(k) No. K945576) (510(k} No. K952867) (510(k) No. K851647) (510(k) No. K96 1438) USE .. Dilatation of Biliary and Dilatation of Gl Indication Other Non-GI Strictures «— Same «— Same a— Sa…	Meadox Surgimed, Inc.	1985	—
*	K961438	Ballon Dilatation Catheter Summary page 3 …r Veclran Fibers for Biliary Dilatation Dilatation Catheter (This 510{k)) (510(k) No. K934411) (510(k) No. K945576) (510(k} No. K952867) (510(k) No. K851647) (510(k) No. K96 1438) USE .. Dilatation of Biliary and Dilatation of Gl Indication Other Non-GI Strictures «— Same «— Same a— Same «— Same Strictures…	Boston Scientific Corp	1996	—

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K010714	Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830	Medi-Globe Corp.	2003	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?

None of the 5 ancestors has a recall.
Of its descendants, K010714 (Medi-Globe Corp., 2003) has gone furthest, with 0 descendants of its own.

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 Modified Olbert® Balloon Catheter products are recommended for biliary tract stenosis/sphincter stenosis and gastrointestinal tract dilatation through a flexible endoscope. The recommended application is printed on the label *

* The recommended application on the label may refer to any combination of transpapillary, pyloric, colonic, anastomotic, and/or esophageal dilatation.

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/K973113 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973113: Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973113

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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