510(k) Report

510(k) · Cleared

Recalled · Class II · 2026

Bardex Lubri-Sil Foley Catheter

K984084510(k) TraditionalCleared Feb 1, 199977-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

Bard Medical Div. · EZL Catheter, Retention Type, Balloon

Cleared on Feb 1, 1999 after a 77-day review. The FDA summary names its predicate without a number. 11 later devices descend from it. It has been recalled once.

Decided
Feb 1, 1999
Review
77 days
Class
Class II
Product code
EZL
Recalls
1
Predicates
0

11 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2020: 1 descendant cleared2009: 1 descendant cleared2014: 1 descendant cleared2007: 1 descendant cleared2010: 1 descendant cleared2017: 1 descendant cleared2022: 2 descendants cleared2023: 1 descendant cleared2026: 1 descendant cleared2024: 1 descendant cleared1995200020052010201520202025
  1. This deviceK984084 Bardex Lubri-Sil Foley CatheterBard Medical Div. · 1999
  2. Descendant · cites it directly · 6 of its ownK070508 Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · Recalled
  3. Descendant · cites it directly · 4 of its ownK091699 Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009
  4. Descendant · cites it directly · 3 of its ownK192034 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone…Pathway, LLC · 2020
  5. Descendant · 2 generations on · 2 of its ownK221625 2-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation · 2022
  6. Descendant · 2 generations on · 2 of its ownK162989 Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12010: 12014: 12017: 12020: 12022: 22023: 12024: 12026: 1
2007high 2 (2022) · low 0 (2008)2026

Most influential descendants

Showing 5 of 11 · See all
  • K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc. · 2007 · cites it directly6descendants
  • K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc. · 2009 · cites it directly4descendants
  • K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley…Pathway, LLC · 2020 · cites it directly3descendants
  • K2216252-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation · 2022 · 2 generations on2descendants
  • K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. · 2017 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K984084Bardex Lubri-Sil Foley CatheterBard Medical Div.1999—
+1K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc.20071
+1K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.2009—
+1K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way…Pathway, LLC2020—
+2K2216252-Way 100% Silicone ClearTract CatheterSilq Technologies Corporation2022—
+2K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201010
201410
201710
202010
202220
202310
202410
202610
FIG. 1 — Lineage of K984084, 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? (2)

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
*—Bardex® All-Silicone Foley Catheter
Named without a submission number
—
*—Bardex® Lubricath® Foley Catheter
Named without a submission number
—

What descends from it? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K070508Bardex Lubri-Sil All-Silicone Lubricious Coated Foley Catheter 6 FRC.R. Bard, Inc.20076
K091699Amsure Hydrophilic Latex Foley CatheterAmsino International, Inc.20094
K192034HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley…Pathway, LLC20203
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?

  • Of its descendants, K070508 (C.R. Bard, Inc., 2007) has gone furthest, with 6 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.

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™ Foley Catheter 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 a nephrostomy tract.

Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Bard Medical Div.

3 FDA decisions under this applicant name. See the company

  • K984136Bardex Lubri-Sil I.C. Foley CatheterBard Medical Div. · 19992 recalls
  • K970110Bard Flexible Endoscopy Injection System (651019)Bard Medical Div. · 1997

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/K984084 · printed Nov 4, 2026

Cite this page

510(k) Report. “K984084: Bardex Lubri-Sil Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984084

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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