510(k) Report

510(k) · Cleared

Cleared

Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes)

K022000510(k) SpecialCleared Jul 19, 200230-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

Spire Biomedical, Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on Jul 19, 2002 as substantially equivalent to K013160 (Spire Biomedical, Inc., 2002) and 2 other predicates after a 30-day review. Its family tree reaches back 2 generations to 2002. 9 later devices descend from it.

Decided
Jul 19, 2002
Review
30 days
Class
Class II
Product code
MSD
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K013160 (2002). 3 ancestors in all, the oldest K002902 (2001). 9 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2006: 2 descendants cleared2002: 2 descendants cleared2005: 1 descendant cleared2004: 1 descendant cleared2007: 2 descendants cleared2009: 1 descendant cleared×2: 2 generations cleared close together, K013160 (2002), K021212 (2002) 200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant4 generations forward: 1 descendant K021212 · 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips · Spire Biomedical, Inc. · 2002K013160 · Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter · Spire Biomedical, Inc. · 20020
  1. Root · 2 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
  2. 1 generation backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  3. This deviceK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  4. Descendant · cites it directly · 3 of its ownK043292 HemocathMed-Conduit, Inc. · 2005
  5. Descendant · 2 generations on · 2 of its ownK062901 Hemocath IIMed-Conduit, Inc. · 2007
  6. Descendant · 3 generations on · 1 of its ownK071202 Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007
  7. Descendant · cites it directly · 1 of its ownK041559 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc. · 2004
  8. Descendant · cites it directly · 1 of its ownK022644 Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2002: 22004: 12005: 12006: 22007: 22009: 1
2002high 2 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 9 · See all
  • K043292HemocathMed-Conduit, Inc. · 2005 · cites it directly3descendants
  • K062901Hemocath IIMed-Conduit, Inc. · 2007 · 2 generations on2descendants
  • K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007 · 3 generations on1descendant
  • K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc. · 2004 · cites it directly1descendant
  • K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc. · 2002 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc.2002—
−1K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated…Spire Biomedical, Inc.2002—
0 (this device)K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc.2002—
+1K043292HemocathMed-Conduit, Inc.2005—
+2K062901Hemocath IIMed-Conduit, Inc.2007—
+3K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc.2007—
+1K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc.2004—
+1K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200410
200510
200620
200720
200910
FIG. 1 — Lineage of K022000, 2002–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 12.4 · 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? (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
*K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc.2002—
*K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips
Summary page 1
…heter, Hemodialysis, Implant (Long-Term) Legally Marketed Devices to Which Substantial Equivalence is Claimed: 1) Spire Biomedical, Inc. Pourchez XpressOTM(KO13160 and K021212) 2) Kendall Tandem-CathTM(for dynamic and static flow comparison - K002902) Device Description: The Pourchez RetrOTMTwin Lumen…
Spire Biomedical, Inc.2002—
*K002902Tandem-Cath 10 FR. Catheter System, Model Multiple Code Numbers
Summary page 1
…bstantial Equivalence is Claimed: 1) Spire Biomedical, Inc. Pourchez XpressOTM(KO13160 and K021212) 2) Kendall Tandem-CathTM(for dynamic and static flow comparison - K002902) Device Description: The Pourchez RetrOTMTwin Lumen Chronic Hemodialysis Catheter with Separated Tips is a flexible radiopaque s…
The Kendall Company20015

Also cleared against K013160: 4 other devices →

What descends from it? (9)

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

NumberDeviceApplicantDecidedDescendants
K043292HemocathMed-Conduit, Inc.20053
K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc.20041
K022644Retro Repair Kit, Model PRRK5Spire Biomedical, Inc.20021
K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.20060
K022620Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtSpire Biomedical, Inc.20020

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?

  • The line of descent spans 0 years and passes through 1 company; a new generation was cleared every 2 months on median.
  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K043292 (Med-Conduit, Inc., 2005) has gone furthest, with 3 descendants of its own.
  • 4 other devices also cite its predicate K013160.

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?

Spire Biomedical, Inc.'s Pourchez RetrOTMSilicone Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic hemodialysis and apheresis. It is a radiopaque silicone catheter designed for percutaneous insertion or insertion via a cutdown.

Indications for use as stated in the FDA summary.

Also cleared against K013160

4 other devices cite the same predicate.

  • K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006
  • K032061Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH, DE27/32SH, DE 31/36SH…Spire Biomedical, Inc. · 200348 recalls
  • K022620Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtSpire Biomedical, Inc. · 2002
  • K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 2002

More from Spire Biomedical, Inc.

16 FDA decisions under this applicant name. See the company

  • K073092Decathlon Twin Lumen Hemodialysis Catheter with Separated Tips, Models DE19SH24, DE23SH28, DE27SH32…Spire Biomedical, Inc. · 2008
  • K073093Decathlon Gold Twin Lumen Hemodialysis Catheter with Separated Tips, Models DEC19SH24, DEC23SH28, DEC23SH32…Spire Biomedical, Inc. · 2008
  • K06344115.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40…Spire Biomedical, Inc. · 200748 recalls
  • K06343115.5 FR Decathlon Gold, Funnel Tips, Coated Hemodialysis Catheter, DFC19SH24, DFC23SH28, DFC27SH32…Spire Biomedical, Inc. · 200748 recalls
  • K062435Repair Kit for Xpresso, Decathlon, and Alta LR CathetersSpire Biomedical, Inc. · 2006

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/K022000 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022000: Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022000

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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