510(k) · Decided
Recalled · Class II · 2021Palindrome RT Chronic Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · MSD Catheter, Hemodialysis, Implanted
Cleared on Aug 30, 2011 as substantially equivalent to K092205 (Covidien Lp, Formerly Registered AS Kendall, 2009) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 2001. 1 of the 7 devices in its family, counting itself, has a Class I recall. It has been recalled 13 times.
- Decided
- Aug 30, 2011
- Review
- 64 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 13
- Predicates
- 2
Its longest line of descent runs back 4 generations to K010399 (2001). 6 ancestors in all, the oldest K002901 (2001). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 3 generations backK040078 Cannon II PlusArrow International, Inc. · 2004 · Recalled
- 2 generations backK092205 Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009
- 1 generation backK111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R)…Covidien · 2011 · Recalled (Class I)
- This deviceK111817 Palindrome RT Chronic CatheterCovidien · 2011
Class I recalls in this family
- K111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen…direct predicate · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −3 | K040078 | Cannon II Plus | Arrow International, Inc. | 2004 | 19 |
| −2 | K092205 | Palindrome P Hemodialysis Catheter | Covidien Lp, Formerly Registered AS Kendall | 2009 | — |
| −1 | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid… | Covidien | 2011 | Class I |
| 0 (this device) | K111817 | Palindrome RT Chronic Catheter | Covidien | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 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.
1 device in this family has 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? (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 |
|---|---|---|---|
| * | K092205 | Palindrome P Hemodialysis CatheterSummary page 1…theter Regulation Number: 21 CFR 876.5540 Product Code: MSD Classification: Class III 3. Predicate Devices: Palindrome"m RT Chronic Catheter (K092205 and Kil1372) 4. Device Description: The PalindroMeTM RT Chronic Catheter is supplied with a detached "proximal end"… | 2009 |
| * | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual… Cleared while this submission was under review Summary page 2…demonstrated that the modified Palindromem RT Chronic Catheter is substantially equivalent to the existing Palindromnem RT Chronic Catheter (K(092205 and KI111372). TMENT OFHEALTH &HUMAN SERVICESPulcHatSeve DDEPAR… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 28, 2021 | Class II | Z-2368-2021 | 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-2369-2021 | 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-2364-2021 | 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-2366-2021 | 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-2358-2021 | 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-2367-2021 | 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-2363-2021 | 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-2362-2021 | 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-2370-2021 | 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-2361-2021 | 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-2359-2021 | 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-2360-2021 | 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-2365-2021 | 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). |
The 5 latest of 13 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 · ◆ on the line of descent in FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 3 of the 6 ancestors have a recall of any class; 1 has a Class I recall.
- 1 other device also cites its predicate K092205.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 PalindromeTM RT Chronic Catheter is intended 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111817 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111817: Palindrome RT 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/K111817
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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