510(k) · Cleared

Cleared

Bard LubriGuard Foley Catheter

K150699510(k) TraditionalCleared Jul 28, 2015132-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

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

Cleared on Jul 28, 2015 as substantially equivalent to K910195 (C.R. Bard, Inc., 1991) after a 132-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.

Decided: Jul 28, 2015
Review: 132 days
Class: Class II
Product code: EZL
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K910195 (1991). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK910195 Bard Hydrogel-Coated Foley CathetersC.R. Bard, Inc. · 1991 · Recalled
This deviceK150699 Bard LubriGuard Foley CatheterC.R. Bard, Inc. · 2015
Descendant · cites it directly · 0 of its ownK180781 Bard Vertus Foley CatheterC.R. Bard, Inc. · 2018

Most influential descendants

Showing 1 of 1 · See all

K180781Bard Vertus Foley CatheterC.R. Bard, Inc. · 2018 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910195	Bard Hydrogel-Coated Foley Catheters	C.R. Bard, Inc.	1991	1
0 (this device)	K150699	Bard LubriGuard Foley Catheter	C.R. Bard, Inc.	2015	—
+1	K180781	Bard Vertus Foley Catheter	C.R. Bard, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0

FIG. 1 — Lineage of K150699, 1991–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K260756 TraumaGuard Intra-Abdominal Pressure-Sensing…score 13.2 · 5 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K910195	Bard Hydrogel-Coated Foley Catheters Summary page 4 …fication: II Product Code: EZL Legally marketed device to which substantial equivalence is claimed: • Bard Hydrogel-Coated Foley Catheters, K910195 Device Description The LubriGuard Foley Catheter is a biocompatible, hydrogel-coated, synthetic polyisoprene Foley catheter use…	C.R. Bard, Inc.	1991	1

Also cleared against K910195: 1 other device →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K180781	Bard Vertus Foley Catheter	C.R. Bard, Inc.	2018	0

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?

Its one ancestor has a recall.
Of its descendants, K180781 (C.R. Bard, Inc., 2018) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K910195.

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. 2015, this device’s year, is highlighted.

FDA decisions per year · EZL

1in 2025

2007high 9 (2018) · low 0 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EZL

123in 2024

2007high 282 (2023) · low 114 (2009)2026

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

Recalls per year · EZL

2in 2024

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	7	186	0	8
2008	2	—	0	6
2009	4	114	0	6
2010	1	—	0	27
2011	2	—	0	79
2012	0	—	0	65
2013	3	151	0	99
2014	2	—	0	229
2015	3	132	0	303
2016	1	—	0	326
2017	2	—	0	571
2018	9	177	0	677
2019	3	266	1	671
2020	4	137	0	712
2021	2	—	0	702
2022	2	—	0	884
2023	3	282	2 (2)	772
2024	5	123	2	1,029
2025	1	—	0	1,381
2026	4	170	2	—

What is it indicated for?

The Bard LubriGuard Foley Catheter is intended for use in the drainage and/or collection and/or measurement of urine. Drainage is accomplished by inserting the catheter through the urethra and into the bladder.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K150699 · printed Nov 6, 2026

Cite this page

510(k) Report. “K150699: Bard LubriGuard Foley Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150699

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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