510(k) Report

510(k) · Decided

Recalled · Class II · 2014

Hemo-Stream Hemodialysis Catheter Set

K023847510(k) TraditionalDecided Apr 30, 2003162-day reviewClass II21 CFR 876.5540Recalls 3

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

Rex Medical · MSD Catheter, Hemodialysis, Implanted

Cleared on Apr 30, 2003 as substantially equivalent to K012365 (Boston Scientific Corp, 2001) after a 162-day review. Its family tree reaches back 1 generation to 2001. 6 later devices descend from it. It has been recalled 3 times.

Decided
Apr 30, 2003
Review
162 days
Class
Class II
Product code
MSD
Recalls
3
Predicates
1

Its longest line of descent runs back 1 generation to K012365 (2001). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2010: 1 descendant cleared2014: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2018: 1 descendant clearedK012365 · Vaxcel Dialysis Catheter · Boston Scientific Corp · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant4 generations forward: 1 descendant5 generations forward: 2 descendants K012365 · Vaxcel Dialysis Catheter · Boston Scientific Corp · 20010+5
  1. Root · 1 generation backK012365 Vaxcel Dialysis CatheterBoston Scientific Corp · 2001
  2. This deviceK023847 Hemo-Stream Hemodialysis Catheter SetRex Medical · 2003
  3. Descendant · cites it directly · 5 of its ownK071422 15.5F Hemo-Stream Hemodialysis Catheter SetRex Medical · 2007
  4. Descendant · 2 generations on · 4 of its ownK102043 Ultrastream Chronic Hemodialysis CatheterRex Medical · 2010 · Recalled
  5. Descendant · 3 generations on · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
  6. Descendant · 4 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
  7. Descendant · 5 generations on · 1 of its ownK173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with…Medical Components, Inc. (dba MedComp) · 2018

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 12010: 12014: 12017: 12018: 12020: 1
2007high 1 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K07142215.5F Hemo-Stream Hemodialysis Catheter SetRex Medical · 2007 · cites it directly5descendants
  • K102043Ultrastream Chronic Hemodialysis CatheterRex Medical · 2010 · 2 generations on4descendants
  • K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · 3 generations on3descendants
  • K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 4 generations on2descendants
  • K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp) · 2018 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K012365Vaxcel Dialysis CatheterBoston Scientific Corp2001—
0 (this device)K023847Hemo-Stream Hemodialysis Catheter SetRex Medical2003—
+1K07142215.5F Hemo-Stream Hemodialysis Catheter SetRex Medical2007—
+2K102043Ultrastream Chronic Hemodialysis CatheterRex Medical20103
+3K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical2014—
+4K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.)2017—
+5K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X…Medical Components, Inc. (dba MedComp)2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201010
201410
201710
201810
202010
FIG. 1 — Lineage of K023847, 2001–2020Source: 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 MSD? 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. #1 K241581 Hemodialysis Catheterscore 12.3 · 11 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K012365Vaxcel Dialysis CatheterBoston Scientific Corp2001—

Also cleared against K012365: 1 other device →

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K07142215.5F Hemo-Stream Hemodialysis Catheter SetRex Medical20075

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 5, 2014Class IIZ-2698-2014Component design/selectionUltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Jun 5, 2014Class IIZ-2696-2014Component design/selectionUltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Jun 5, 2014Class IIZ-2697-2014Component design/selectionUltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K071422 (Rex Medical, 2007) has gone furthest, with 5 descendants of its own.
  • 1 other device also cites its predicate K012365.

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

2007: 72008: 32009: 62010: 42011: 72012: 22013: 52014: 82015: 12016: 22017: 22018: 22019: 12020: 42021: 42025: 1
2007high 8 (2014) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSD

153in 2021

2007: 92 days median2008: 89 days median2009: 81 days median2010: 116 days median2011: 70 days median2013: 105 days median2014: 246 days median2020: 106 days median2021: 153 days median
2007high 246 (2014) · low 70 (2011)2026

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

Recalls per year · MSD

1in 2013

2008: 472009: 492010: 112011: 242013: 12026 (partial year): 4, 4 Class I
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

2007: 1182008: 1742009: 1732010: 3062011: 2682012: 3672013: 3632014: 5062015: 5502016: 5322017: 4842018: 4632019: 6452020: 4012021: 5232022: 6102023: 5422024: 8412025: 1,054
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20077920118
200838947174
200968149173
2010411611306
201177024268
20122—0367
201351051363
201482460506
20151—0550
20162—0532
20172—0484
20182—0463
20191—0645
202041060401
202141530523
20220—0610
20230—0542
20240—0841
20251—01,054
20260—4 (4)—

What is it indicated for?

The Hemo-StreamTMHemodialysis Catheter Set is designed for chronic

hemodialysis and apheresis.

Indications for use as stated in the FDA summary.

Also cleared against K012365

1 other device cites the same predicate.

  • K07142215.5F Hemo-Stream Hemodialysis Catheter SetRex Medical · 2007

More from Rex Medical

13 FDA decisions under this applicant name. See the company

  • K120346Cleaner Rotational Thrombectomy SystemRex Medical · 2012
  • K113103Splitwire Percutaneous Transluminal Angioplasty Scoring DeviceRex Medical · 2012
  • K102043Ultrastream Chronic Hemodialysis CatheterRex Medical · 20103 recalls
  • K091029Cleaner Rotational Thrombectomy System (9 MM X 65 CM) and (9 MM X 120 CM)Rex Medical · 2010
  • K081410Option Vena Cava FilterRex Medical · 2009

Recent decisions in MSD

The MSD category page

  • K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025
  • K210461End CapMedical Components Inc (Medcomp) · 2021
  • K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2021
  • K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. · 2021
  • K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc. · 2021

https://510kreport.com/device/K023847 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023847: Hemo-Stream Hemodialysis Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023847

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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