510(k) · Decided
Recalled · Class II · 201514.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall · MSD Catheter, Hemodialysis, Implanted
Cleared on Nov 3, 2006 as substantially equivalent to K060509 (Tyco Healthcare Group, 2006) and 1 other predicate after a 56-day review. Its family tree reaches back 3 generations to 1999. 2 of the 14 devices in its family, counting itself, have a Class I recall. 6 later devices descend from it. It has been recalled 24 times.
- Decided
- Nov 3, 2006
- Review
- 56 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 24
- Predicates
- 2
Its longest line of descent runs back 3 generations to K974236 (1999). 7 ancestors in all, the oldest K861563 (1986). 6 later devices descend from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 2 generations backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- 1 generation backK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- This deviceK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006
- Descendant · cites it directly · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
- Descendant · 4 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
- Descendant · 5 generations on · 1 of its ownK173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with…Medical Components, Inc. (dba MedComp) · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 6 · See all- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · cites it directly5descendants
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien · 2013 · 2 generations on4descendants
- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · 3 generations on3descendants
- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 4 generations on2descendants
- K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp) · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −2 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| −1 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| 0 (this device) | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | — |
| +1 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +2 | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | Class I |
| +3 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
| +4 | K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017 | — |
| +5 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X… | Medical Components, Inc. (dba MedComp) | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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.
2 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 K241581 Hemodialysis Catheterscore 12.4 · 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 |
|---|---|---|---|
| * | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin CoatingSummary page 1…gnated Sleeve (Palindrome TM Sapphire T M ) is substantially equivalent to Kendall's 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating (Palindrome TM Emerald' , K060509) in intended use, T M materials, physical characteristi… | 2006 |
| * | K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)Summary page 1…TM RubyTM) cleared for Hemodialysis Catheter with Silver Impregnated Sleeve (Palindrome marketing via K060972 on August 4, 2006. K060972 is within the same device classification regulation (876.5540) as the unmodified predicate device, and… | 2006 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112477 | Palindrome H, SI, Hsi Chronic Catheter Class I | 2011 | 5 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2015 | Class II | Z-1897-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1891-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1892-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1903-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1910-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1893-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1888-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1909-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1900-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1902-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1901-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1895-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1896-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1899-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1904-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1898-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1911-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1894-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1890-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1889-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1905-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1906-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1908-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1907-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
The 5 latest of 24 recalls; the web page lists all.
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.
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 13 Class I recalls
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K112477 (Covidien, 2011) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K060509.
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 Kendall 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome TM SapphireTM) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown.
The performance of the heparin coating on this catheter in reducing platelet adhesion on the catheter surface for up to 720 hours of dialysis treatment is supported by bench and animal testing.
The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days is supported by bench and animal testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062671 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062671
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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