510(k) Report

510(k) · Decided

Decided

Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters

K060288510(k) TraditionalDecided Sep 1, 2006207-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 Sep 1, 2006 as substantially equivalent to K013160 (Spire Biomedical, Inc., 2002) and 5 other predicates after a 207-day review. Its family tree reaches back 4 generations to 2002. 3 of the 10 devices in its family, counting itself, have a Class I recall.

Decided
Sep 1, 2006
Review
207 days
Class
Class II
Product code
MSD
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K013160 (2002). 9 ancestors in all, the oldest K895417 (1990). No later device cites it as a predicate yet. 3 of the 10 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year cleared 2000: 1 other ancestor, 1 with a Class I recall11996: 1 other ancestor2001: 1 other ancestor1990: 2 other ancestors, 2 with a Class I recall2×3: 3 generations cleared close together, K013160 (2002), K021212 (2002), K022000 (2002) K041559 · 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 · Spire Biomedical, Inc. · 20041990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors, 1 with a Class I recall12 generations back: 3 other ancestors, 2 with a Class I recall2 K041559 · 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model #RS50SH55,RS50NH55,RE50SH55 & RE50NH55 · Spire Biomedical, Inc. · 2004K022000 · Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and Without Side Holes) · Spire Biomedical, Inc. · 2002K021212 · 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 · 4 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
  2. 3 generations backK021212 24CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  3. 2 generations backK022000 Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with…Spire Biomedical, Inc. · 2002
  4. 1 generation backK041559 55CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc. · 2004
  5. This deviceK060288 Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006

Class I recalls in this family

  • K993933 14 FR Two-Lumen Hemodialysis Catherization Kit…direct predicate · 2000
  • K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
  • K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kit2 generations back · 1990
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K013160Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc.2002—
−3K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated…Spire Biomedical, Inc.2002—
−2K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips…Spire Biomedical, Inc.2002—
−1K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…Spire Biomedical, Inc.2004—
0 (this device)K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199022
199610
200011
200110
FIG. 1 — Lineage of K060288, 2002–2006Source: 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.

3 devices in this family have a Class I recall. 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? (6)

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 1
…vices to Which Substantial Equivalence is Claimed: 1. Spire Biomedical, Inc.'s Pourchez XpressO® Twin Lumnen Chronic Hemodialysis Catheter with Separated Tips (K01 3160 & K021212). 2. Spire Biomedical, Inc.'s Pourchez RetrO® ~Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (K…
Spire Biomedical, Inc.2002—
*K02121224CM Pourchez Xpresso Twin Lumen Chronic Hemodialysis Catheter with Separated Tips
Summary page 1
…ich Substantial Equivalence is Claimed: 1. Spire Biomedical, Inc.'s Pourchez XpressO® Twin Lumnen Chronic Hemodialysis Catheter with Separated Tips (K01 3160 & K021212). 2. Spire Biomedical, Inc.'s Pourchez RetrO® ~Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (K022000 & K…
Spire Biomedical, Inc.2002—
*K022000Pourchez Retro Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (with and…
Summary page 1
…Catheter with Separated Tips (K01 3160 & K021212). 2. Spire Biomedical, Inc.'s Pourchez RetrO® ~Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (K022000 & K041 559). 3. Electro-Biology, Inc.'s X Fix~ Dynafix TM System - SC Bone Screws with silver coating (K961433). 4. A…
Spire Biomedical, Inc.2002—
*K04155955CM Pourchez Retro Safe Trac Twin Lumen Hemodialysis Catheter Model…
Summary page 1
…r with Separated Tips (K01 3160 & K021212). 2. Spire Biomedical, Inc.'s Pourchez RetrO® ~Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (K022000 & K041 559). 3. Electro-Biology, Inc.'s X Fix~ Dynafix TM System - SC Bone Screws with silver coating (K961433). 4. Arrow Intern…
Spire Biomedical, Inc.2004—
*K961433Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws
Summary page 1
…Hemodialysis Catheter with Separated Tips (K022000 & K041 559). 3. Electro-Biology, Inc.'s X Fix~ Dynafix TM System - SC Bone Screws with silver coating (K961433). 4. Arrow International, Inc., Two-Lumnen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter…
Electro-Biology, Inc.1996—
*K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…
Summary page 1
…ews with silver coating (K961433). 4. Arrow International, Inc., Two-Lumnen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Catheter (K993933) Device Description: Spire Biomedical, Inc.'s RetrO SilverTm and XpressO SilverTm are radiopaque silicone catheters that have…
Arrow Intl., Inc.2000Class I

Also cleared against K013160: 4 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (3 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
  • K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
  • K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
  • 4 of the 9 ancestors have a recall of any class; 3 have a Class I recall.
  • 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 RetrO SilverTM and XpressO SilverTM Coated Twin Lumen Chronic Hemodialysis Catheters with Separated Tips are designed for chronic hemodialysis and apheresis. They are radiopaque silicone catheters designed for percutaneous insertion or insertion via a cutdown. Catheters longer than 40cm are intended for femoral vein insertion.

The silver coating on the catheter may reduce bacterial surface colonization for up to two months. This performance was supported by literature citing clinical testing.

Indications for use as stated in the FDA summary.

Also cleared against K013160

4 other devices cite the same predicate.

  • 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
  • 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/K060288 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060288: Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060288

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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