510(k) · Cleared
Recalled · 200915.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
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 Feb 12, 2007 as substantially equivalent to K060155 (Spire Biomedical, Inc., 2006) and 5 other predicates after a 90-day review. Its family tree reaches back 3 generations to 2002. It has been recalled 48 times.
- Decided
- Feb 12, 2007
- Review
- 90 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 48
- Predicates
- 6
Its longest line of descent runs back 3 generations to K013160 (2002). 8 ancestors in all, the oldest K925626 (1993). No later device cites it as a predicate yet.
- Root · 3 generations backK013160 Pourchez Xpresso Twin Limen Chronic Hemodialysis CatheterSpire Biomedical, Inc. · 2002
- 2 generations backK032061 Decathlon Twin Lumen Hemodialysis with Separated Tips, Models…Spire Biomedical, Inc. · 2003 · Recalled
- 1 generation backK040509 Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24…Spire Biomedical, Inc. · 2004 · Recalled
- This deviceK063441 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24…Spire Biomedical, Inc. · 2007
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 | K032061 | Decathlon Twin Lumen Hemodialysis with Separated Tips, Models DE19/24SH… | Spire Biomedical, Inc. | 2003 | 48 |
| −1 | K040509 | Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28… | Spire Biomedical, Inc. | 2004 | 48 |
| 0 (this device) | K063441 | 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28… | Spire Biomedical, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060155 | 15.5FR Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated TipsSummary page 1…hich Substantial Equivalence is Claimed: * Spire Biomedical, Inc.'s 15.5Fr Decathlon Coated Twin Lumen Chronic Hemodialysis Catheter with Separated Tips (K060155) * Spire Biomedical, Inc.'s 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter (K040509) *… | 2006 |
| * | K040509 | Alta LR Fixed Tip Chronic Hemodialysis Catheter, Models AL19NH24, AL23NH28, AL27NH32…Summary page 1…emodialysis Catheter with Separated Tips (K060155) * Spire Biomedical, Inc.'s 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter (K040509) * Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K 933586) * Diametrics Paratrend intravascular bloo… | 2004 |
| * | K925626 | Maxima Plus Hollow Fiber OxygenatorSummary page 1…Spire Biomedical, Inc.'s 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter (K040509) * Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K 933586) * Diametrics Paratrend intravascular blood gas sensor catheter (K970906) * Cordis Bx Velocity coronar… | 1993 |
| * | K933586 | Minimax Plus Hollow Fiber Oxygenator (with or Without Medtronic/Carmeda Bioactive SurfaceSummary page 1…edical, Inc.'s 15.5Fr Alta LR Twin Lumen Fixed Tip Chronic Hemodialysis Catheter (K040509) * Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K 933586) * Diametrics Paratrend intravascular blood gas sensor catheter (K970906) * Cordis Bx Velocity coronary stent (P900… | 1994 |
| * | K970906 | Paratrend 7 Multiparameter Senior and Satellite Monitor System with Paratrend 7 Plus…Summary page 1…Catheter (K040509) * Medtronic Maxima cardiopulmonary bypass circuit (K925626 and K 933586) * Diametrics Paratrend intravascular blood gas sensor catheter (K970906) * Cordis Bx Velocity coronary stent (P90043/S024) 16 Snjr~~~ Spire Biomedical, Inc., a One… | 1997 |
| * | P900043/ | BX Velocity (TM) with Hepacoat (TM) on Raptor (TM) Stent System for Coronary ArteriesSummary page 3…opulmonary bypass circuit (K925626 and K933586) 3. Diametrics Paratrend intravascular blood gas sensor catheter (K970906) 4. Cordis Bx Velocity coronary stent (P900043/S024) Performance Data: A series of physical, mechanical, and biological tests were conducted on the predicate, coated Decathlon cath… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2009 | Not classified | Z-0288-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0289-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0290-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0299-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0301-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0302-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0304-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0306-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0309-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0311-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0312-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0294-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0295-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0296-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0297-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0300-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0303-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0307-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0308-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0314-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0316-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0317-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0318-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0319-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0321-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0330-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0291-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0292-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0293-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0298-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0305-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0310-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0313-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0315-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0320-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0322-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0323-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0324-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0325-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0327-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0328-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0332-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0334-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0335-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0329-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0331-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0333-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
| Oct 23, 2009 | Not classified | Z-0326-2010 | Process control | There is a possibility that the catheter tubing could separate from the hub/bifurcation of the device. If this occurs, bleeding is the primary clinical complication likely to result from catheter tubing/hub separation. A second potential… |
The 5 latest of 48 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.7 years on median.
- 3 of the 8 ancestors have a recall of any class.
- 2 other devices also cite its predicate K060155.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MSD
1in 2025
2007high 8 (2014) · low 0 (2022)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · MSD
153in 2021
2007high 246 (2014) · low 70 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MSD
1in 2013
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
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
| 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?
Spire Biomedical Inc's Alta Gold, Coated Twin Lumen Chronic Hemodialysis Catheter with fixed tips is designed for chronic hemodialysis and apheresis. It is a radiopaque polyurethane with a heparin coating, designed for percutaneous insertion or insertion via cutdown. The ability of the Carmeda End point Bonded Heparin Coating to reduce clotting is supported by in-vitro testing. Catheters longer than 40cm are intended for femoral vein insertion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063441: 15.5FR Alta Gold, Coated Hemodialysis Catheter, Model ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063441
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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