510(k) · Cleared
Recalled · 2008Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tyco Healthcare Group · NYU Catheter, Hemodialysis, Implanted, Coated
Cleared on Jun 23, 2006 as substantially equivalent to K043272 (Kendall, 2004) and 2 other predicates after a 116-day review. Its family tree reaches back 2 generations to 1999. 2 of the 12 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 23, 2006
- Review
- 116 days
- Class
- Class II
- Product code
- NYU
- Recalls
- 4
- Predicates
- 3
Its longest line of descent runs back 2 generations to K974236 (1999). 4 ancestors in all, the oldest K973760 (1998). 7 later devices descend from it, 2 citing it directly. 2 of the 12 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 1 generation backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- This deviceK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006
- Descendant · cites it directly · 6 of its ownK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- Descendant · cites it directly · 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 · 4 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 7 · See all- K06267114.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve…Kendall · 2006 · cites it directly6descendants
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · cites it directly5descendants
- 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
- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −1 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| 0 (this device) | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | — |
| +1 | 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 |
| +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 | — |
| +4 | 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 |
|---|---|---|
| 1998 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 1 |
| 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.
2 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? (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…c Hemnodialysis Catheter with Heparin Coating 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 modification attributed to the predic… | 2004 |
| * | K991320 | Medcomp Duo-Flow II Catheter with Lubricious HeparinSummary page 1…ng platelet adhesion along the catheter surface. The following are predicate devices for the heparmn coating: * MedComp® Duo-Coat Double Lumen Hemodialysis Catheter (K991320) * Medtronic AFFINITY Hollow Fiber Oxygenator with Trillium Biosurface (K973760) 510(k) Premarket Notificatio… | 1999 |
| * | K973760 | Affinity Hollow Fiber Oxygenator with Trillium Biopassive SurfaceSummary page 1…for the heparmn coating: * MedComp® Duo-Coat Double Lumen Hemodialysis Catheter (K991320) * Medtronic AFFINITY Hollow Fiber Oxygenator with Trillium Biosurface (K973760) 510(k) Premarket Notification Kendall PalindromeTM EmeraldTM 14.5 Fr Chronic Hemodialysis Catheter with Heparin… | 1998 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 19, 2008 | Not classified | Z-0408-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Sep 19, 2008 | Not classified | Z-0409-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Sep 19, 2008 | Not classified | Z-0411-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
| Sep 19, 2008 | Not classified | Z-0410-2009 | Mixed-up of materials/components | Incorrect size of the Venetrac stylets (an optional accessory). They are too short and cannot be used. |
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 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 14 Class I recalls
What does this lineage say?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K062671 (Kendall, 2006) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K043272.
How does its category compare?
All NYU devicesNYU Catheter, Hemodialysis, Implanted, Coated: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Palindrome Emerald 14.5 fr Cuffed catheter is intended for acute and chronic hemodialysis, apheresis, and infusion. 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. It may be inserted either percutaneously or by cutdown.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060509 · printed Nov 5, 2026
Cite this page
510(k) Report. “K060509: Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060509
Report an extraction error
Are you the manufacturer?
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