510(k) · Cleared
Recalled · Class II · 2015Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kendall · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 4, 2006 as substantially equivalent to K043272 (Kendall, 2004) and 1 other predicate after a 119-day review. Its family tree reaches back 1 generation to 1986. 2 of the 10 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 38 times.
- Decided
- Aug 4, 2006
- Review
- 119 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 38
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861563 (1986). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly. 2 of the 10 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK861563 Vitaguard Percutaneous Infection Control KitVitaphore Corp. · 1986
- This deviceK060972 Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated…Kendall · 2006
- Descendant · cites it directly · 6 of its ownK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall · 2006 · cites it directly6descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861563 | Vitaguard Percutaneous Infection Control Kit | Vitaphore Corp. | 1986 | — |
| 0 (this device) | K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve… | Kendall | 2006 | — |
| +1 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K043272 | Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipSummary page 1…r Impregnated Sleeve (Palindrome TM Rub yTM) is substantially equivalent to the Kendall PalindromeTM 14.5 Fr Chronic Hemnodialysis Catheter with Slotted Symmetrical Tip (K043272) in intended use, materials, physical characteristics, and performance characteristics. The modification attributed to the predic… | 2004 |
| * | K861563 | Vitaguard Percutaneous Infection Control KitSummary page 1…. This silver impregnated sleeve is substantially equivalent in intended use and performance characteristics as the legally marketed VitaGuardTM silver impregnated cuff (K86 1563). 5 10(k) Premarket Notification Kendall 14.5 Fr Chronic Hemodialysis Catheter with Silver Impregnated Sleeve (Pa… | 1986 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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-1883-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1879-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1872-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1875-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1880-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1874-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1863-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1862-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1850-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z1856-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1884-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1864-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1858-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z1855-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1853-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1870-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1865-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1857-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1877-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1876-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1885-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1854-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1886-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1859-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1878-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1873-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1882-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1861-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1860-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1851-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1866-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1887-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1852-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1871-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1881-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1869-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1867-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1868-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
The 5 latest of 38 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?
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 Silver Impregnated Sleeve (PalindromeTM RubyTM) is intended for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cutdown. Catheters greater than 40 cm implant length are indicated for femoral insertion. The performance of the silver impregnated sleeve in reducing colonization on the catheter surface for up to 30 days was supported by bench and animal testing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060972 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060972: Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060972
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