# K060972: Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)

- Pathway: 510(k) (Traditional)
- Applicant: Kendall
- Decided: Aug 4, 2006 after 119 days
- Product code: MSD (Catheter, Hemodialysis, Implanted)
- Device class: 2
- Regulation: 21 CFR 876.5540
- Recalls of this device: 38 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861563 (1986). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
2 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043272: Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical Tip, Kendall (2004) Summary page 1.
- K861563: Vitaguard Percutaneous Infection Control Kit, Vitaphore Corp. (1986) Summary page 1.

## Most influential descendants
- K062671: 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire) (2006), 6 descendants of its own
- K112477: Palindrome H, SI, Hsi Chronic Catheter (2011), 5 descendants of its own
- K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath (2013), 4 descendants of its own
- K140884: Symetrex Long Term Hemodialysis Catheter (2014), 3 descendants of its own
- K171618: Symetrex Long Term Hemodialysis Catheter (2017), 2 descendants of its own

## Recalls of this device
- Apr 23, 2015 · Class II · Z-1883-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1879-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1872-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1875-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1880-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1874-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1863-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1862-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1850-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z1856-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1884-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1864-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1858-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z1855-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1853-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1870-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1865-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1857-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1877-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1876-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1885-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1854-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1886-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1859-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1878-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1873-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1882-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1861-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1860-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1851-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1866-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1887-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1852-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1871-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1881-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1869-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1867-2015: Catheters may not meet antimicrobial specification
- Apr 23, 2015 · Class II · Z-1868-2015: Catheters may not meet antimicrobial specification

## Indications for use
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.

Source page: https://510kreport.com/device/K060972
Methodology: https://510kreport.com/methodology