510(k) · Decided
Recalled · Class I · 2023Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)...
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 4, 2011 as substantially equivalent to K043272 (Kendall, 2004) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 2001. 3 of the 16 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Aug 4, 2011
- Review
- 80 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 3 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 3 generations to K010399 (2001). 5 ancestors in all, the oldest K002901 (2001). 10 later devices descend from it, 4 citing it directly. 3 of the 16 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 2 generations backK040078 Cannon II PlusArrow International, Inc. · 2004 · Recalled
- 1 generation backK092205 Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009
- This deviceK111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R)…Covidien · 2011
- Descendant · cites it directly · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- 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 · cites it directly · 2 of its ownK182443 Pristine Hemodialysis CatheterPristine Access Technologies, Ltd. · 2019
- Descendant · 3 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · cites it directly5descendants
- 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
- K182443Pristine Hemodialysis CatheterPristine Access Technologies, Ltd. · 2019 · cites it directly2descendants
- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −2 | K040078 | Cannon II Plus | Arrow International, Inc. | 2004 | 19 |
| −1 | K092205 | Palindrome P Hemodialysis Catheter | Covidien Lp, Formerly Registered AS Kendall | 2009 | — |
| 0 (this device) | K111372 | Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid… | Covidien | 2011 | — |
| +1 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +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 | — |
| +1 | K182443 | Pristine Hemodialysis Catheter | Pristine Access Technologies, Ltd. | 2019 | — |
| +3 | 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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 1 |
| 2013 | 1 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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? (3)
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…on Number: 21 CER 876.5540 Product Code: MSD Classification: Class Ill 3. Predicate Devices: Tat PalindromeTM Symmetric Tip Dual Lumen Catheter (K043272) Mahurkar® MaxidTM Dual Lumen Catheter (K002901) PalindromeTM RT Reverse-Tunneled Catheter (K092205) 4. Device… | 2004 |
| * | K002901 | Kendall 14.5 FR Maxid Cuffed Dual Lumen CatheterSummary page 1…Classification: Class Ill 3. Predicate Devices: Tat PalindromeTM Symmetric Tip Dual Lumen Catheter (K043272) Mahurkar® MaxidTM Dual Lumen Catheter (K002901) PalindromeTM RT Reverse-Tunneled Catheter (K092205) 4. Device Description: The Tal PalindromeTM Symmetric Ti… | 2001 |
| * | K092205 | Palindrome P Hemodialysis CatheterSummary page 1…Tat PalindromeTM Symmetric Tip Dual Lumen Catheter (K043272) Mahurkar® MaxidTM Dual Lumen Catheter (K002901) PalindromeTM RT Reverse-Tunneled Catheter (K092205) 4. Device Description: The Tal PalindromeTM Symmetric Tip Dual Lumen Catheter has a radiopaque shaft with two large i… | 2009 |
What descends from it? (10)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 22, 2023 | Class II | Z-2632-2023 | Under Investigation by firm | Some catheter kits labeled as 23 cm implant length incorrectly included catheters of 28 cm implant length; the actual catheter implant length is identifiable based upon the correct labeling on the catheter body. |
| Jun 8, 2022 | Class I | Z-1320-2022 | 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-1316-2022 | 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. |
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 · Cites it directly · ◆ in the 2013 descendants bar of FIG. 14 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.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K112477 (Covidien, 2011) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K043272.
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 device is indicated for acute and chronic heinodialysis, apheresis, and infusion. It may be inserted percutaneously or by cut down. Catheters with greater than 40 cm implant length are indicated for femnoral placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111372 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111372: Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual Lumen Catheter, Palindrome (TM)....” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111372
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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