510(k) Report

510(k) · Cleared

Cleared

24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips

K021212510(k) SpecialCleared May 17, 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 May 17, 2002 as substantially equivalent to K013160 (Spire Biomedical, Inc., 2002) after a 30-day review. Its family tree reaches back 1 generation to 2002. 10 later devices descend from it.

Decided
May 17, 2002
Review
30 days
Class
Class II
Product code
MSD
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013160 (2002). 10 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2002: 3 descendants cleared2006: 2 descendants cleared2005: 1 descendant cleared2004: 1 descendant cleared2007: 2 descendants cleared2009: 1 descendant clearedK013160 · Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter · Spire Biomedical, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant K013160 · Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter · Spire Biomedical, Inc. · 20020+5
  1. Root · 1 generation backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
  2. This deviceK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  3. Descendant · cites it directly · 9 of its ownK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  4. Descendant · 2 generations on · 3 of its ownK043292 HemocathMed-Conduit, Inc. · 2005
  5. Descendant · 3 generations on · 2 of its ownK062901 Hemocath IIMed-Conduit, Inc. · 2007
  6. Descendant · 4 generations on · 1 of its ownK071202 Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007
  7. Descendant · 2 generations on · 1 of its ownK041559 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc. · 2004

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2002: 32004: 12005: 12006: 22007: 22009: 1
2002high 3 (2002) · low 0 (2003)2026

Most influential descendants

Showing 5 of 10 · See all
  • K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…Spire Biomedical, Inc. · 2002 · cites it directly9descendants
  • K043292HemocathMed-Conduit, Inc. · 2005 · 2 generations on3descendants
  • K062901Hemocath IIMed-Conduit, Inc. · 2007 · 3 generations on2descendants
  • K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc. · 2007 · 4 generations on1descendant
  • K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc. · 2004 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc.2002—
0 (this device)K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated…Spire Biomedical, Inc.2002—
+1K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc.2002—
+2K043292HemocathMed-Conduit, Inc.2005—
+3K062901Hemocath IIMed-Conduit, Inc.2007—
+4K071202Dermaport Percutaneous Vascular Access System (Pvas)Dermaport, Inc.2007—
+2K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200410
200510
200620
200720
200910
FIG. 1 — Lineage of K021212, 2002–2009Source: 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? (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
*K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter
Summary page 2
…essO™ Catheter consists of the identical materials of construction as the Pourchez XpressO™ catheters listed within our initial 510(K) Premarket Notification Submission (K013160). Additionally, the 24cm Pourchez XpressO™ catheter has similar flow rates and priming volumes as the MedComp Ash Split Cath™.…
Spire Biomedical, Inc.2002—
*—Medical Components, Inc. Ash Split Cath™
Named without a submission number
—

Also cleared against K013160: 4 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…Spire Biomedical, Inc.20029
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?

  • Its one ancestor has no recall.
  • Of its descendants, K022000 (Spire Biomedical, Inc., 2002) has gone furthest, with 9 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?

The Pourchez XpressO™ is a silicone twin lumen catheter with separated tips designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.

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

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
  • K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes)Spire 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/K021212 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021212: 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021212

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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