510(k) Report

510(k) · Cleared

Recalled · Class II · 2023

Quantum TTC Biliary Balloon Dilator

K171223510(k) TraditionalCleared Jun 16, 201751-day reviewClass II21 CFR 876.5010Recalls 7

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

Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Jun 16, 2017 as substantially equivalent to K935094 (Wilson-Cook Medical, Inc., 1995) after a 51-day review. Its family tree reaches back 1 generation to 1995. It has been recalled 7 times.

Decided
Jun 16, 2017
Review
51 days
Class
Class II
Product code
FGE
Recalls
7
Predicates
1

Its longest line of descent runs back 1 generation to K935094 (1995). No later device cites it as a predicate yet.

Reference device: K040800 · Wilosn-Cook Biliary Dilation Balloon · Wilson-Cook Medical, Inc. · 2004K935094 · Balloon Dilation Catheter · Wilson-Cook Medical, Inc. · 1995 · recalled19952000200520102015
K935094 · Balloon Dilation Catheter · Wilson-Cook Medical, Inc. · 1995 · recalled0
  1. Root · 1 generation backK935094 Balloon Dilation CatheterWilson-Cook Medical, Inc. · 1995 · Recalled
  2. This deviceK171223 Quantum TTC Biliary Balloon DilatorWilson-Cook Medical, Inc. · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935094Balloon Dilation CatheterWilson-Cook Medical, Inc.19952
0 (this device)K171223Quantum TTC Biliary Balloon DilatorWilson-Cook Medical, Inc.2017—
FIG. 1 — Lineage of K171223, 1995–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K935094Balloon Dilation Catheter
Summary page 4
…liary Catheter and Accessories 21 CFR 876.5010, FGE Class II Predicate Device: Quantum T.T.C Balloon Dilation Catheter K935094, 01/24/1995 Reference Device: Wilson-Cook Biliary Dilation Balloon K040800 06/25/2004 Intended Use The Quantum…
Wilson-Cook Medical, Inc.19952
†K040800Wilosn-Cook Biliary Dilation BalloonWilson-Cook Medical, Inc.2004—

Also cleared against K935094: 3 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)

Recalls of this device

DateClassRecallRoot causeReason
Nov 3, 2023Class IIZ-0461-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…
Nov 3, 2023Class IIZ-0463-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…
Nov 3, 2023Class IIZ-0457-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…
Nov 3, 2023Class IIZ-0459-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…
Nov 3, 2023Class IIZ-0462-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…
Nov 3, 2023Class IIZ-0460-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…
Nov 3, 2023Class IIZ-0458-2024Under Investigation by firmNonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the…

The 5 latest of 7 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • 3 other devices also cite its predicate K935094.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · FGE

7in 2025

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

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

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
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

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

What is it indicated for?

The Quantum TTC Biliary Balloon Dilator is used to dilate strictures of the biliary tree.

Indications for use as stated in the FDA summary.

Also cleared against K935094

3 other devices cite the same predicate.

  • K090183Hercules 3 Stage Wire Guided Dilation BalloonCook Endoscopy · 2009
  • K061937Cook Endoscopy Esophageal Dilation BalloonCook Endoscopy · 2006
  • K040800Wilosn-Cook Biliary Dilation BalloonWilson-Cook Medical, Inc. · 2004

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K171223 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171223: Quantum TTC Biliary Balloon Dilator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171223

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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