510(k) · Cleared

Cleared

Long-Term Hemodialysis Catheters with Biobloc Coating

K053589510(k) TraditionalCleared Apr 13, 2006111-day reviewClass II21 CFR 876.5540

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

Bard Access Systems, Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on Apr 13, 2006 as substantially equivalent to K030020 (C.R. Bard, Inc., 2003) and 2 other predicates after a 111-day review. Its family tree reaches back 6 generations to 1998. 3 of the 13 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.

Decided: Apr 13, 2006
Review: 111 days
Class: Class II
Product code: MSD
Recalls: None
Predicates: 3

Its longest line of descent runs back 6 generations to K981994 (1998). 11 ancestors in all, the oldest K895417 (1990). 1 later device descends from it, 1 citing it directly. 3 of the 13 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK981994 Vascath Opti-Flow Long Term Dual Lumen Hemodialysis CatheterC.R. Bard, Inc. · 1998
5 generations backK012562 Medcomp 14.5F Double Lumen Hemodialysis CatheterMedical Components, Inc. · 2002
4 generations backK020465 Medcomp Ash Split-Cath IIMedcomp · 2002
3 generations backK030020 Hemosplit Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2003
2 generations backK033294 Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM…C.R. Bard, Inc. · 2003
1 generation backK051748 Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis…C.R. Bard, Inc. · 2005 · Recalled
This deviceK053589 Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006
Descendant · cites it directly · 0 of its ownK063245 Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007 · Recalled

Class I recalls in this family

K993933 14 FR Two-Lumen Hemodialysis Catherization Kit…direct predicate · 2000
K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kit2 generations back · 1990

Most influential descendants

Showing 1 of 1 · See all

K063245Elutia Coated Closed Surgical Wound DrainBacterin International, Inc. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K981994	Vascath Opti-Flow Long Term Dual Lumen Hemodialysis Catheter	C.R. Bard, Inc.	1998	—
−5	K012562	Medcomp 14.5F Double Lumen Hemodialysis Catheter	Medical Components, Inc.	2002	—
−4	K020465	Medcomp Ash Split-Cath II	Medcomp	2002	—
−3	K030020	Hemosplit Long-Term Hemodialysis Catheter	C.R. Bard, Inc.	2003	—
−2	K033294	Hemosplit XK, Hemosplit XK Catheter, 16FR X 42 CM, Kit;16FR X 19 CM, Kit with…	C.R. Bard, Inc.	2003	—
−1	K051748	Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters	C.R. Bard, Inc.	2005	13
0 (this device)	K053589	Long-Term Hemodialysis Catheters with Biobloc Coating	Bard Access Systems, Inc.	2006	—
+1	K063245	Elutia Coated Closed Surgical Wound Drain	Bacterin International, Inc.	2007	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	2	2
1998	1	0
2000	1	1
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K053589, 1998–2007Source: 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.

3 devices in this family have a Class I recall. 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 MSD device

#1 K241581 Hemodialysis Catheterscore 12.4 · 11 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? (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.

Type	Number	Device	Applicant	Decided	Recalls
*	K030020	Hemosplit Long-Term Hemodialysis Catheter Summary page 1 ….t~k ~) . .nceDate<- HemoSplit Long-Term Hemodialysis Catheter K030020 6/16/2003 HemoStar Long-Term Hemodialysis Catheter T M…	C.R. Bard, Inc.	2003	—
*	K051748	Hemoglide Series and Hemoglide Star Series XK Long-Term Hemodialysis Catheters Summary page 1 …16/2003 HemoStar Long-Term Hemodialysis Catheter T M K051748 8/12/2005 The predicate device for the BioBIocTm coating is: Device Name: Two-Lumen Hemo…	C.R. Bard, Inc.	2005	13
*	K993933	14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue… Summary page 2 …Blood Access Device Classification Panel: Gastroenterology and Renal 14 Fr Two-Lumen Hemodialysis Catheterization Kit with K993933 9/14/2000 Blue FlexTip® ARROWg+ard Blue® Catheter for High Volume Infusions 5.4 Intended Use…	Arrow Intl., Inc.	2000	Class I

Also cleared against K030020: 3 other devices →

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
K063245	Elutia Coated Closed Surgical Wound Drain	Bacterin International, Inc.	2007	0

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
4 of the 11 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K063245 (Bacterin International, Inc., 2007) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K030020.

How does its category compare?

All MSD devices

MSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSD

1in 2025

2007high 8 (2014) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSD

153in 2021

2007high 246 (2014) · low 70 (2011)2026

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

Recalls per year · MSD

1in 2013

2007high 49 (2009) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MSD

1,054in 2025

2007high 1,054 (2025) · low 118 (2007)2025

MAUDE reports naming product code MSD, 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	92	0	118
2008	3	89	47	174
2009	6	81	49	173
2010	4	116	11	306
2011	7	70	24	268
2012	2	—	0	367
2013	5	105	1	363
2014	8	246	0	506
2015	1	—	0	550
2016	2	—	0	532
2017	2	—	0	484
2018	2	—	0	463
2019	1	—	0	645
2020	4	106	0	401
2021	4	153	0	523
2022	0	—	0	610
2023	0	—	0	542
2024	0	—	0	841
2025	1	—	0	1,054
2026	0	—	4 (4)	—

What is it indicated for?

HemoSplit® and HemoStarTM long-term hemodialysis catheters with BioBlocTM coating are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein.

Catheters greater than 40 cm are intended for femoral vein insertion.

The performance of the BioBloCTM coating on the HemoSplit® and HemoStarTM catheters in reducing bacterial adhesion for 21 days was supported by in vitro testing.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K053589 · printed Nov 4, 2026

Cite this page

510(k) Report. “K053589: Long-Term Hemodialysis Catheters with Biobloc Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053589

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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