510(k) · Cleared
ClearedPourchez Xpresso Twin Limen Chronic Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spire Biomedical, Inc. · MSD Catheter, Hemodialysis, Implanted
Cleared on Apr 11, 2002 after a 202-day review. The FDA summary names its predicate without a number. 16 later devices descend from it.
- Decided
- Apr 11, 2002
- Review
- 202 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 5 citing it directly.
- This deviceK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- Descendant · cites it directly · 10 of its ownK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- Descendant · cites it directly · 9 of its ownK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- Descendant · cites it directly · 4 of its ownK032061 Decathlon Twin Lumen Hemodialysis with Separated Tips, Models…Spire Biomedical, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 3 of its ownK043292 HemocathMed-Conduit, Inc. · 2005
- Descendant · 3 generations on · 2 of its ownK062901 Hemocath IIMed-Conduit, Inc. · 2007
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSpire Biomedical, Inc. · 2002 · cites it directly10descendants
- K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…Spire Biomedical, Inc. · 2002 · cites it directly9descendants
- K032061Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH…Spire Biomedical, Inc. · 2003 · cites it directly4descendants
- K043292HemocathMed-Conduit, Inc. · 2005 · 2 generations on3descendants
- K062901Hemocath IIMed-Conduit, Inc. · 2007 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| +1 | K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated… | Spire Biomedical, Inc. | 2002 | — |
| +1 | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips… | Spire Biomedical, Inc. | 2002 | — |
| +1 | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH… | Spire Biomedical, Inc. | 2003 | 48 |
| +2 | K043292 | Hemocath | Med-Conduit, Inc. | 2005 | — |
| +3 | K062901 | Hemocath II | Med-Conduit, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
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 K241581 Hemodialysis Catheterscore 12.3 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Medical Components, Inc. Ash Split Cath™ Named without a submission number | |
| * | — | Quinton Instruments Company, Adult Perm-Cath™ Named without a submission number |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021212 | 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips | 2002 | 10 |
| K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and… | 2002 | 9 |
| K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH, DE23/28SH… | 2003 | 4 |
| K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters | 2006 | 0 |
| K022620 | Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt | 2002 | 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?
- Of its descendants, K021212 (Spire Biomedical, Inc., 2002) has gone furthest, with 10 descendants of its own.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · MSD
1,054in 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?
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.
https://510kreport.com/device/K013160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013160: Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013160
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026