510(k) · Decided
DecidedPalindrome P Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien Lp, Formerly Registered AS Kendall · MSD Catheter, Hemodialysis, Implanted
Cleared on Oct 30, 2009 as substantially equivalent to K043272 (Kendall, 2004) and 1 other predicate after a 100-day review. Its family tree reaches back 2 generations to 2001. 3 of the 15 devices in its family, counting itself, have a Class I recall. 11 later devices descend from it.
- Decided
- Oct 30, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K010399 (2001). 3 ancestors in all. 11 later devices descend from it, 2 citing it directly. 3 of the 15 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK010399 Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC…Diatek, Inc. · 2001 · Recalled
- 1 generation backK040078 Cannon II PlusArrow International, Inc. · 2004 · Recalled
- This deviceK092205 Palindrome P Hemodialysis CatheterCovidien Lp, Formerly Registered AS Kendall · 2009
- Descendant · cites it directly · 10 of its ownK111372 Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R)…Covidien · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 5 of its ownK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 4 of its ownK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
- Descendant · 3 generations on · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
- Descendant · 2 generations on · 2 of its ownK182443 Pristine Hemodialysis CatheterPristine Access Technologies, Ltd. · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 11 · See all- K111372Tal Pallindrome (TM) Symmetric Tip Dual Lumen Catheter, Mahurkar (R) Maxid (TM) Dual…Covidien · 2011 · cites it directly10descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations on5descendants
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Covidien · 2013 · 2 generations on4descendants
- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · 3 generations on3descendants
- K182443Pristine Hemodialysis CatheterPristine Access Technologies, Ltd. · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010399 | Diatek Cannon-Cath #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC… | Diatek, Inc. | 2001 | 2 |
| −1 | K040078 | Cannon II Plus | Arrow International, Inc. | 2004 | 19 |
| 0 (this device) | 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 |
| +2 | K112477 | Palindrome H, SI, Hsi Chronic Catheter | Covidien | 2011 | Class I |
| +2 | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic… | Covidien | 2013 | Class I |
| +3 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
| +2 | K182443 | Pristine Hemodialysis Catheter | Pristine Access Technologies, Ltd. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 2 |
| 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? (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 |
|---|---|---|---|
| * | K043272 | Pallindrome 14.5FR Chronic Hemodialysis Catheter with Slotted Symmetrical TipSummary page 1…med: The PalindromeTM P Hemodialysis Catheter is substantially equivalent to the Kendall PalindromeTM 14.5 Fr Chronic Hemodialysis Catheter with Slotted Symmetrical Tip (K043272) in intended use, materials, physical characteristics, and performance characteristics. The insertion procedure of the catheter i… | 2004 |
| * | K040078 | Cannon II PlusSummary page 1…ed use, materials, physical characteristics, and performance characteristics. The insertion procedure of the catheter is equivalent to the predicate Arrow Cannon H Plus (K040078). Device Description: The Palindrome P Hemodialysis Catheter has a radiopaque polyurethane shaft with two large inner lumens des… | 2004 |
What descends from it? (11)
See all 112 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)
No FDA recall names this device.
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 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 12 Class I recalls
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations on · ◆ 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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 8 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K111372 (Covidien, 2011) has gone furthest, with 10 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. 2009, 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 Reverse Tunneled Catheter 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 Palindrome reverse-tunneled catheter repair kit is intended for the repair of the hub/back end assembly (extension tubing, luer adapter(s) or clamp(s)) or to repair the hub snap connector component(s). A repair can only be made if the tubing length between the hub snap connector and the exit sit is a minimum of 5.5 cm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092205: Palindrome P Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092205
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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