510(k) Report

510(k) · Cleared

Cleared

3 Way Silicone Foley Balloon Catheter

K091767510(k) TraditionalCleared Oct 9, 2009114-day reviewClass II21 CFR 876.5130

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

Cook Urological, Inc. · EZL Catheter, Retention Type, Balloon

Cleared on Oct 9, 2009 as substantially equivalent to K951106 (Cook Urological, Inc., 1995) and 5 other predicates after a 114-day review. Its family tree reaches back 3 generations to 1990. 1 later device descends from it.

Decided
Oct 9, 2009
Review
114 days
Class
Class II
Product code
EZL
Recalls
None
Predicates
6

Its longest line of descent runs back 3 generations to K896053 (1990). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2008: 1 other ancestor2007: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor2004: 1 other ancestor2018: 1 descendant clearedK896053 · All Silicone Foley Catheter · Rochester Medical Corp. · 1990K981612 · All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter · Rochester Medical Corp. · 1998K013276 · All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) · Sewoon Medical Co., Ltd. · 20021990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K013276 · All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque) · Sewoon Medical Co., Ltd. · 2002K981612 · All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way Radiopaque Foley Catheter · Rochester Medical Corp. · 1998K896053 · All Silicone Foley Catheter · Rochester Medical Corp. · 19900
  1. Root · 3 generations backK896053 All Silicone Foley CatheterRochester Medical Corp. · 1990
  2. 2 generations backK981612 All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley…Rochester Medical Corp. · 1998
  3. 1 generation backK013276 All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd. · 2002
  4. This deviceK091767 3 Way Silicone Foley Balloon CatheterCook Urological, Inc. · 2009
  5. Descendant · cites it directly · 0 of its ownK181616 PSM 3-Way Silicone Foley CatheterPathway, LLC · 2018

Most influential descendants

Showing 1 of 1 · See all
  • K181616PSM 3-Way Silicone Foley CatheterPathway, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K896053All Silicone Foley CatheterRochester Medical Corp.1990—
−2K981612All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter…Rochester Medical Corp.1998—
−1K013276All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)Sewoon Medical Co., Ltd.2002—
0 (this device)K0917673 Way Silicone Foley Balloon CatheterCook Urological, Inc.2009—
+1K181616PSM 3-Way Silicone Foley CatheterPathway, LLC2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199510
200010
200410
200710
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201810
FIG. 1 — Lineage of K091767, 1990–2018Source: 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), 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 EZL? 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 EZL device

  1. #1 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 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? (6)

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
*K951106Silicone Foley Catheter
Summary page 1
…y Silicone Foley Balloon Catheter issimilar with respect to indications for use and technology to exis'ting predicate devices: COOK- Silicone Foley Catheter (51 0(k) No. 951106), C.R.Bard - Bardex®)All Silicone 3-Way Foley (51 0(k) No. 002868), Well Lead - All Silicone Foley Catheters (51 0(k) No. 082815)…
Cook Urological, Inc.1995—
*K002868Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard…
Summary page 1
…tions for use and technology to exis'ting predicate devices: COOK- Silicone Foley Catheter (51 0(k) No. 951106), C.R.Bard - Bardex®)All Silicone 3-Way Foley (51 0(k) No. 002868), Well Lead - All Silicone Foley Catheters (51 0(k) No. 082815), Sewoon Medical Co., LTD - All-Silicone Foley Balloon Catheter (5…
C.R. Bard, Inc.2000—
*K082815Well Lead Silicone and Latex Foley Catheters
Summary page 1
…OK- Silicone Foley Catheter (51 0(k) No. 951106), C.R.Bard - Bardex®)All Silicone 3-Way Foley (51 0(k) No. 002868), Well Lead - All Silicone Foley Catheters (51 0(k) No. 082815), Sewoon Medical Co., LTD - All-Silicone Foley Balloon Catheter (510(k) No. 013276), Rochester Medical Corp.- Two-Way Radiopaque…
Well Lead Medical Instruments2008—
*K013276All-Silicone Foley Balloon Catheter (Two Way; Three Way, Radiopaque)
Summary page 1
…-Way Foley (51 0(k) No. 002868), Well Lead - All Silicone Foley Catheters (51 0(k) No. 082815), Sewoon Medical Co., LTD - All-Silicone Foley Balloon Catheter (510(k) No. 013276), Rochester Medical Corp.- Two-Way Radiopaque Foley Catheter (51 0(k) No. 981612), C.R. Bard - Bardex®)Lubri-Sil® 3-Way Foley Cat…
Sewoon Medical Co., Ltd.2002—
*K981612All Silicone Foley Catheter, Two-Way Foley Catheter, Three-Way Foley Catheter, Two-Way…
Summary page 1
…) No. 082815), Sewoon Medical Co., LTD - All-Silicone Foley Balloon Catheter (510(k) No. 013276), Rochester Medical Corp.- Two-Way Radiopaque Foley Catheter (51 0(k) No. 981612), C.R. Bard - Bardex®)Lubri-Sil® 3-Way Foley Catheter (51 0(k) No. 070558). Please refer to Attachment C for marketing and FDA in…
Rochester Medical Corp.1998—
*K070558Bardex Lubri-Sil and Bardex Lubri-Sil I.C. Anti-Infective All-Silicone Foley Catheters
Summary page 1
…er (510(k) No. 013276), Rochester Medical Corp.- Two-Way Radiopaque Foley Catheter (51 0(k) No. 981612), C.R. Bard - Bardex®)Lubri-Sil® 3-Way Foley Catheter (51 0(k) No. 070558). Please refer to Attachment C for marketing and FDA information regarding the predicate devices. Device Description: The 3 Way…
C.R. Bard, Inc.2007—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K181616PSM 3-Way Silicone Foley CatheterPathway, LLC20180

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?

  • The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K181616 (Pathway, LLC, 2018) has gone furthest, with 0 descendants of its own.

How does its category compare?

All EZL devices

EZL Catheter, Retention Type, Balloon: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · EZL

1in 2025

2007: 72008: 22009: 42010: 12011: 22013: 32014: 22015: 32016: 12017: 22018: 92019: 32020: 42021: 22022: 22023: 32024: 52025: 12026 (partial year): 4
2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZL

123in 2024

2007: 186 days median2009: 114 days median2013: 151 days median2015: 132 days median2018: 177 days median2019: 266 days median2020: 137 days median2023: 282 days median2024: 123 days median2026 (partial year): 170 days median
2007high 282 (2023) · low 114 (2009)2026

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

Recalls per year · EZL

2in 2024

2019: 12023: 2, 2 Class I2024: 22026 (partial year): 2
2007high 2 (2023) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · EZL

1,381in 2025

2007: 82008: 62009: 62010: 272011: 792012: 652013: 992014: 2292015: 3032016: 3262017: 5712018: 6772019: 6712020: 7122021: 7022022: 8842023: 7722024: 1,0292025: 1,381
2007high 1,381 (2025) · low 6 (2008)2025

MAUDE reports naming product code EZL, 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
2007718608
20082—06
2009411406
20101—027
20112—079
20120—065
20133151099
20142—0229
201531320303
20161—0326
20172—0571
201891770677
201932661671
202041370712
20212—0702
20222—0884
202332822 (2)772
2024512321,029
20251—01,381
202641702—

What is it indicated for?

Used to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. Urinary tract access is generally accomplished by insertion of the catheter through the urethra and into the bladder, but may also be accomplished by suprapubic placement or by Nephrostomy.

Indications for use as stated in the FDA summary.

More from Cook Urological, Inc.

104 FDA decisions under this applicant name. See the company

  • K102141Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)Cook Urological, Inc. · 2011
  • K082939Cook Fetal Membrane Manipulator, Model -FMM-122400Cook Urological, Inc. · 2009
  • K082066Tao Brush I.U.M.C. Endometrial SamplerCook Urological, Inc. · 20081 recall
  • K082536Cook Wire GuidesCook Urological, Inc. · 20087 recalls
  • K082319Injekt Filiform Injection NeedleCook Urological, Inc. · 2008

Recent decisions in EZL

The EZL category page

  • K261141OpenFlo Urinary CatheterUrolution Medical, Inc. · 2026
  • K260756TraumaGuard Intra-Abdominal Pressure-Sensing System (000-0221)Sentinel Medical Technologies, · 2026
  • K262056Rusch Latex Gold Foley CatheterTeleflex Medical Sdn. Bhd. · 2026
  • K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
  • K243011Silicone Urethral Catheter (Silicone Urethral Catheter)Guangdong Ecan Medical Co., Ltd. · 2025

https://510kreport.com/device/K091767 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091767: 3 Way Silicone Foley Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091767

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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