510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR

K070508510(k) TraditionalCleared Mar 9, 200715-day reviewClass II21 CFR 876.5130Recalls 1

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

C.R. Bard, Inc. · EZL Catheter, Retention Type, Balloon

Cleared on Mar 9, 2007 as substantially equivalent to K000723 (Rochester Medical Corp., 2000) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1999. 6 later devices descend from it. It has been recalled once.

Decided
Mar 9, 2007
Review
15 days
Class
Class II
Product code
EZL
Recalls
1
Predicates
3

Its longest line of descent runs back 1 generation to K984084 (1999). 3 ancestors in all. 6 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors2009: 1 descendant cleared2014: 1 descendant cleared2010: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedK984084 · Bardex Lubri-Sil Foley Catheter · Bard Medical Div. · 1999 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K984084 · Bardex Lubri-Sil Foley Catheter · Bard Medical Div. · 1999 · recalled0
  1. Root · 1 generation backK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999 · Recalled
  2. This deviceK070508 Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007
  3. Descendant · cites it directly · 4 of its ownK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
  4. Descendant · 2 generations on · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017
  5. Descendant · 3 generations on · 1 of its ownK212077 Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023
  6. Descendant · 4 generations on · 0 of its ownK252537 Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026
  7. Descendant · cites it directly · 0 of its ownK140667 Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd. · 2014

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12014: 12017: 12023: 12026: 1
2009high 1 (2009) · low 0 (2011)2026

Most influential descendants

Showing 5 of 6 · See all
  • K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009 · cites it directly4descendants
  • K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · 2 generations on2descendants
  • K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc. · 2023 · 3 generations on1descendant
  • K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd. · 2026 · 4 generations on0descendants
  • K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K984084Bardex Lubri-Sil Foley CatheterBard Medical Div.19991
0 (this device)K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc.2007—
+1K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.2009—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.2017—
+3K212077Teleflex Rusch SoftSimplastic Foley CathetersTeleflexmedical, Inc.2023—
+4K252537Rusch SoftSimplastic Foley CathetersTeleflex Medical Sdn. Bhd.2026—
+1K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201410
201710
202310
202610
FIG. 1 — Lineage of K070508, 1999–2026Source: 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? (3)

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
*K000723Hydrophilic Silicone Foley Catheter and Personal Catheter (Hydrophilic and…
Summary page 3
…5-2 ? 5.8 PREDICATE DEVICES K000723 - Rochester Medical Silicone Hydrophilic coated Foley catheters K984084 - Bardex® All-Silicone Lubri-Sil® Lubr…
Rochester Medical Corp.200026
*K984084Bardex Lubri-Sil Foley Catheter
Summary page 3
…? 5.8 PREDICATE DEVICES K000723 - Rochester Medical Silicone Hydrophilic coated Foley catheters K984084 - Bardex® All-Silicone Lubri-Sil® Lubricious coated Foley catheter, 2- way. K002868 - B…
Bard Medical Div.19991
*K002868Bard All-Silicone 3-Way Foley Catheter; Bard Lubri-Sil 3-Way Foley Catheter; Bard…
Summary page 3
…ilicone Hydrophilic coated Foley catheters K984084 - Bardex® All-Silicone Lubri-Sil® Lubricious coated Foley catheter, 2- way. K002868 - Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley catheter, 3- way. B…
C.R. Bard, Inc.2000—

Also cleared against K000723: 3 other devices →

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094
K140667Well Lead Hydrophilic Silicone Foley CatheterWell Lead Medical Co., Ltd.20140

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 25, 2026Class IIZ-3115-2026Under Investigation by firmDue to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 3 ancestors have a recall of any class.
  • Of its descendants, K091699 (Amsino International, Inc., 2009) has gone furthest, with 4 descendants of its own.
  • 3 other devices also cite its predicate K000723.

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. 2007, 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?

The Bardex® Lubri-Sil® All-Silicone Lubricious Coated Foley Catheter 6 Fr is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.

Indications for use as stated in the FDA summary.

Also cleared against K000723

3 other devices cite the same predicate.

  • K172247Magic3 Go Intermittent Urinary CatheterC.R. Bard, Inc. · 20172 recalls
  • K122785Hydrosil; Magic; Personal CatheterRochester Medical Corp. · 20133 recalls
  • K033477Hydrophilic-Antibacterial Intermittent Catheter, Intermittent Catheter Closed System KitRochester Medical Corp. · 20043 recalls

More from C.R. Bard, Inc.

711 FDA decisions under this applicant name. See the company

  • P800002/S036Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web WebberC.R. Bard, Inc. · 2026
  • P800002/S035Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven WebC.R. Bard, Inc. · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • P170042/S015Covera™ Vascular Covered StentC.R. Bard, Inc. · 2026
  • K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc. · 2026

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/K070508 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070508: Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070508

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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