510(k) · Decided
Decided55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55
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 Jul 30, 2004 as substantially equivalent to K022000 (Spire Biomedical, Inc., 2002) after a 50-day review. Its family tree reaches back 3 generations to 2002. 1 later device descends from it.
- Decided
- Jul 30, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K013160 (2002). 4 ancestors in all, the oldest K002902 (2001). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 2 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- 1 generation backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
- This deviceK041559 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK060288 Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K013160 | Pourchez Xpresso Twin Limen Chronic Hemodialysis Catheter | Spire Biomedical, Inc. | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K041559 | 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model… | Spire Biomedical, Inc. | 2004 | — |
| +1 | K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters | Spire Biomedical, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022000 | Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…Summary page 1…s to Which Substantial Equivalence is Claimed: 1) Spire Biomedical, Inc. Pourchez RetrO Twin Lumen Silicone Chronic Hemodialysis Catheter with Separated Tips "K022000." Device Description: 55cm Pourchez RetrOTM Silicone Twin Lumen Chronic Hemodialysis Catheter with Separated Tips.… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters | 2006 | 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?
- The line of descent spans 2 years and passes through 1 company; a new generation was cleared every 2 months on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K060288 (Spire Biomedical, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K022000.
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 55cm Pourchez RetrO Twin Lumen Chronic Hemodialysis Catheter with Separated Tips is designed for chronic (long-term) hemodialysis and apheresis. It is designed for percutaneous insertion or insertion via cutdown.
Catheters longer than 40cm can be used for femoral vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041559: 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041559
Report an extraction error
Are you the manufacturer?
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