510(k) · Cleared
Recalled · Class I · 2025Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · MSD Catheter, Hemodialysis, Implanted
Cleared on Jan 31, 2013 as substantially equivalent to K111372 (Covidien, 2011) and 1 other predicate after a 112-day review. Its family tree reaches back 5 generations to 1999. 3 of the 19 devices in its family, counting itself, have a Class I recall. 4 later devices descend from it. It has been recalled 49 times, including 4 Class I recalls.
- Decided
- Jan 31, 2013
- Review
- 112 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 49 (4 Class I)
- Predicates
- 2
Its longest line of descent runs back 5 generations to K974236 (1999). 14 ancestors in all, the oldest K861563 (1986). 4 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 · 5 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 4 generations backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- 3 generations backK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- 2 generations backK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- 1 generation backK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- This deviceK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013
- Descendant · cites it directly · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
- Descendant · 2 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
- Descendant · 3 generations on · 1 of its ownK173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with…Medical Components, Inc. (dba MedComp) · 2018
- Descendant · 3 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 4 of 4 · See all- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · cites it directly3descendants
- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 2 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 · 3 generations on1descendant
- K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −4 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| −3 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| −2 | 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 |
| 0 (this device) | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | — |
| +1 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
| +2 | K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017 | — |
| +3 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X… | Medical Components, Inc. (dba MedComp) | 2018 | — |
| +3 | 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 |
|---|---|---|
| 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.
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? (5)
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 |
|---|---|---|---|
| * | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Summary page 1…Product Code(s): MSD, NYU Classification: Class III 3. Predicate Devices: Palindrome TM Symmetric Tip Dual Lumen Catheter K1 11372 PalindromeTM RT Reverse-Tunneled Catheter PalindromeTM H Chronic Catheter… | 2011 |
| * | K112477 | Palindrome H, SI, Hsi Chronic CatheterSummary page 1…er K1 11372 PalindromeTM RT Reverse-Tunneled Catheter PalindromeTM H Chronic Catheter KI112477 PalindromeTM SI Chronic Catheter PalindromeTM HSI Chronic Catheter 4. Device Description: The PalindromeTM… | 2011 |
| * | — | Palindrome RT Reverse-Tunneled Catheter Named without a submission number | |
| * | — | Palindrome SI Chronic Catheter Named without a submission number | |
| * | — | Palindrome HSI Chronic Catheter Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140884 | Symetrex Long Term Hemodialysis Catheter | 2014 | 3 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 23, 2025 | Class II | Z-1886-2025 | Packaging | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Class II | Z-1885-2025 | Packaging | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Class II | Z-1889-2025 | Packaging | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Class II | Z-1888-2025 | Packaging | Potential breach of sterile barrier packaging. |
| Apr 23, 2025 | Class II | Z-1887-2025 | Packaging | Potential breach of sterile barrier packaging. |
| Mar 15, 2024 | Class II | Z-1635-2024 | Process control | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating |
| Mar 15, 2024 | Class II | Z-1634-2024 | Process control | Products may not be heparin coated as indicated on the label-leads to a potential loss of benefit due to the absence of the heparin coating |
| Jun 8, 2022 | Class I | Z-1312-2022 | 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-1315-2022 | 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-1314-2022 | 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-1313-2022 | 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. |
| May 28, 2021 | Class II | Z-2371-2021 | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| May 28, 2021 | Class II | Z-2375-2021 | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| May 28, 2021 | Class II | Z-2372-2021 | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| May 28, 2021 | Class II | Z-2374-2021 | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| May 28, 2021 | Class II | Z-2373-2021 | Labeling design | This voluntary withdrawal is being conducted to implement point-of-use labeling on each device and enhancements to the Instructions for Use (IFU). |
| Oct 14, 2015 | Class II | Z-0329-2016 | Packaging process control | Incorrectly packaged with a 90 degree bend at the distal tip |
| Oct 14, 2015 | Class II | Z-0331-2016 | Packaging process control | Incorrectly packaged with a 90 degree bend at the distal tip |
| Oct 14, 2015 | Class II | Z-0332-2016 | Packaging process control | Incorrectly packaged with a 90 degree bend at the distal tip |
| Oct 14, 2015 | Class II | Z-0330-2016 | Packaging process control | Incorrectly packaged with a 90 degree bend at the distal tip |
| Oct 14, 2015 | Class II | Z-0333-2016 | Packaging process control | Incorrectly packaged with a 90 degree bend at the distal tip |
| Apr 23, 2015 | Class II | Z-1879-2015 | 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 |
| Apr 23, 2015 | Class II | Z-1903-2015 | 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-1910-2015 | 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-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-1884-2015 | 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-1870-2015 | 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-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-1911-2015 | 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-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-1887-2015 | 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-1869-2015 | 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-1868-2015 | Nonconforming Material/Component | Catheters may not meet antimicrobial specification |
The 5 latest of 49 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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
- 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
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 8 of the 14 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K140884 (Phase One Medical, 2014) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K111372.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 Palindrome Precision Symmetric Tip Dual Lumen Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement. The Palindrome Precision RT Reverse-Tunneled Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down.…
Read the full statement (282 words)
The Palindrome Precision Symmetric Tip Dual Lumen Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral placement.
The Palindrome Precision RT Reverse-Tunneled Catheter is indicated for acute and chronic hemodialysis, apheresis, and infusion. It may be inserted either percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femoral insertion.
The Palindrome Precision 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 Palindrome Precision 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 Palindrome Precision 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/K123196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123196: Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi Chronic Cath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123196
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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