510(k) · Decided
Recalled · Class I · 2022Palindrome H, SI, Hsi Chronic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · NYU Catheter, Hemodialysis, Implanted, Coated
Cleared on Sep 28, 2011 as substantially equivalent to K060509 (Tyco Healthcare Group, 2006) and 3 other predicates after a 30-day review. Its family tree reaches back 4 generations to 1999. 3 of the 19 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it. It has been recalled 65 times, including 3 Class I recalls.
- Decided
- Sep 28, 2011
- Review
- 30 days
- Class
- Class II
- Product code
- NYU
- Recalls
- 65 (3 Class I)
- Predicates
- 4
Its longest line of descent runs back 4 generations to K974236 (1999). 13 ancestors in all, the oldest K861563 (1986). 5 later devices descend from it, 1 citing it directly. 3 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 3 generations backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- 2 generations backK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- 1 generation backK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- This deviceK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011
- Descendant · cites it directly · 4 of its ownK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
- Descendant · 2 generations on · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
- Descendant · 3 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
- Descendant · 4 generations on · 1 of its ownK173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with…Medical Components, Inc. (dba MedComp) · 2018
- Descendant · 4 generations on · 0 of its ownK202176 Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien · 2013 · cites it directly4descendants
- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · 2 generations on3descendants
- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 3 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 · 4 generations on1descendant
- K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −3 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| −2 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| −1 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
| 0 (this device) | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | — |
| +1 | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | Class I |
| +2 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
| +3 | K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017 | — |
| +4 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X… | Medical Components, Inc. (dba MedComp) | 2018 | — |
| +4 | K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | Medical Components, Inc. (dba MedComp) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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…Regulation Number: 21 JFR 876.5540 Product Code(s): MSD, NYU Classification: Class IlI 3. Predicate Devices: Pal irhomeTM 1HChronic Catheter (1(060509) Palindromeir' SI Chronic Catheter (1(060972) PalindromTM HSI Chronic Catheter (1(062671) Modified Chroni… | 2006 |
| * | K060972 | Kedall 14.5 FR Chronic Hemodialysis Catheter W/Silver Impregnated Sleeve (Palindrome Ruby)Summary page 1…ode(s): MSD, NYU Classification: Class IlI 3. Predicate Devices: Pal irhomeTM 1HChronic Catheter (1(060509) Palindromeir' SI Chronic Catheter (1(060972) PalindromTM HSI Chronic Catheter (1(062671) Modified Chronic Heniodialysis Catheters (1(111372) 4. Device Descr… | 2006 |
| * | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Summary page 1…. Predicate Devices: Pal irhomeTM 1HChronic Catheter (1(060509) Palindromeir' SI Chronic Catheter (1(060972) PalindromTM HSI Chronic Catheter (1(062671) Modified Chronic Heniodialysis Catheters (1(111372) 4. Device Description: Thle Pal ildroinerNI H1Churnic Cath… | 2006 |
| * | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Summary page 1…r (1(060509) Palindromeir' SI Chronic Catheter (1(060972) PalindromTM HSI Chronic Catheter (1(062671) Modified Chronic Heniodialysis Catheters (1(111372) 4. Device Description: Thle Pal ildroinerNI H1Churnic Catheter with Heparin coating has a rad iopaqute polyuir… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter… Class I | 2013 | 4 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 8, 2022 | Class I | Z-1319-2022 | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. |
| Jun 8, 2022 | Class I | Z-1317-2022 | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. |
| Jun 8, 2022 | Class I | Z-1318-2022 | Process control | There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use. |
| Apr 23, 2015 | Class II | Z-1911-2015 | 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-1902-2015 | 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-1889-2015 | 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-1873-2015 | 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-1857-2015 | 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-1885-2015 | 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-1886-2015 | 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-1859-2015 | 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-1861-2015 | 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-1903-2015 | 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-1863-2015 | 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-1865-2015 | 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-1898-2015 | 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-1876-2015 | 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-1854-2015 | 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-1894-2015 | 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-1890-2015 | 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-1905-2015 | 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-1878-2015 | 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-1882-2015 | 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-1862-2015 | 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-1853-2015 | 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-1883-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
| Apr 23, 2015 | Class II | Z-1897-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
The 5 latest of 50 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.
- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter…Covidien · 2011 · Direct predicate · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.9 years on median.
- 7 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K123196 (Covidien, 2013) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K060509.
How does its category compare?
All NYU devicesNYU Catheter, Hemodialysis, Implanted, Coated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · NYU
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · NYU
Too few NYU 510(k)s in any year since 2007 to give a median.
Recalls per year · NYU
5in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NYU
5in 2025
MAUDE reports naming product code NYU, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 4 | 0 |
| 2009 | 0 | — | 0 | 10 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 0 | — | 0 | 11 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 5 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The PalindromeTM H Chronic Catheter is indicated 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 PalindromeTM SI Chronic Catheter is indicated for acute and chronic hemodialysis, apheresis…
Read the full statement (200 words)
The PalindromeTM H Chronic Catheter is indicated 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 PalindromeTM SI Chronic Catheter is indicated 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 is supported by bench and animal testing.
The PalindromeTM HSI Chronic Catheter is indicated 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/K112477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112477: Palindrome H, SI, Hsi Chronic Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112477
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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