510(k) Report

510(k) · Cleared

Cleared

Taut Balloon Catheter, Model 50640

K011018510(k) TraditionalCleared Jun 22, 200179-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

Taut, Inc. · GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Cleared on Jun 22, 2001 after a 79-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 22, 2001
Review
79 days
Class
Class II
Product code
GCA
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK011018 Taut Balloon Catheter, Model 50640Taut, Inc. · 2001
  2. Descendant · cites it directly · 1 of its ownK173414 Advance Biliary Balloon CatheterCook Incorporated · 2018
  3. Descendant · 2 generations on · 0 of its ownK212582 SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K173414Advance Biliary Balloon CatheterCook Incorporated · 2018 · cites it directly1descendant
  • K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011018Taut Balloon Catheter, Model 50640Taut, Inc.2001—
+1K173414Advance Biliary Balloon CatheterCook Incorporated2018—
+2K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
202210
FIG. 1 — Lineage of K011018, 2001–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCA? 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 GCA device

  1. #1 K253013 Disposable Stone Retrieval Balloon Catheterscore 12.2 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K173414Advance Biliary Balloon CatheterCook Incorporated20181

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?

  • Of its descendants, K173414 (Cook Incorporated, 2018) has gone furthest, with 1 descendant of its own.

How does its category compare?

All GCA devices

GCA Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCA

1in 2024

2007: 12017: 12018: 22019: 12020: 22021: 12022: 12024: 12026 (partial year): 1
2007high 2 (2018) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCA

Too few GCA 510(k)s in any year since 2007 to give a median.

Recalls per year · GCA

No recall names GCA since 2007.

Adverse event reports per year · GCA

24in 2025

2007: 62008: 362009: 342010: 122011: 102012: 92013: 102014: 112015: 202016: 142017: 852018: 382019: 382020: 202021: 82022: 182023: 112024: 142025: 24
2007high 85 (2017) · low 6 (2007)2025

MAUDE reports naming product code GCA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—06
20080—036
20090—034
20100—012
20110—010
20120—09
20130—010
20140—011
20150—020
20160—014
20171—085
20182—038
20191—038
20202—020
20211—08
20221—018
20230—011
20241—014
20250—024
20261—0—

More from Taut, Inc.

16 FDA decisions under this applicant name. See the company

  • K023261Adapt Balloon Open Access Port, Model 41244Taut, Inc. · 2002
  • K021731Adapt Open Access Port, Model 41233Taut, Inc. · 20022 recalls
  • K003703Taut-Insufflation NeedleTaut, Inc. · 2001
  • K010007Adapt Laparoscopic Port & Adapt Reducer CapTaut, Inc. · 20013 recalls
  • K992904Mini-PortTaut, Inc. · 1999

Recent decisions in GCA

The GCA category page

  • K253013Disposable Stone Retrieval Balloon CatheterZhejiang Soudon Medical Technology Co., Ltd. · 2026
  • K232752Stone Extraction Balloon…Jiangsu Vedkang Medical Science and Technology Co., Ltd. · 2024
  • K212582SpyGlass Discover Balloon Dilation CatheterBoston Scientific Corporation · 2022
  • K210660Stone Retrieval Balloon CatheterAnrei Medical (Hangzhou) Co., Ltd. · 2021
  • K200173Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd. · 2020

https://510kreport.com/device/K011018 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011018: Taut Balloon Catheter, Model 50640.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011018

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026