510(k) · Decided
DecidedSymetrex Long Term Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phase One Medical · MSD Catheter, Hemodialysis, Implanted
Cleared on Nov 26, 2014 as substantially equivalent to K102043 (Rex Medical, 2010) and 1 other predicate after a 233-day review. Its family tree reaches back 6 generations to 1999. 3 of the 24 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it.
- Decided
- Nov 26, 2014
- Review
- 233 days
- Class
- Class II
- Product code
- MSD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K974236 (1999). 20 ancestors in all, the oldest K861563 (1986). 3 later devices descend from it, 1 citing it directly. 3 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK974236 Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146…Medical Components, Inc. · 1999
- 5 generations backK991320 Medcomp Duo-Flow II Catheter with Lubricious HeparinMedical Components, Inc. · 1999
- 4 generations backK060509 Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with…Tyco Healthcare Group · 2006 · Recalled
- 3 generations backK062671 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and…Kendall · 2006 · Recalled
- 2 generations backK112477 Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · Recalled (Class I)
- 1 generation backK123196 Palindrome Precision H Chronic Catheter, Palindrome Precision SI…Covidien · 2013 · Recalled (Class I)
- This deviceK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
- Descendant · cites it directly · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
- Descendant · 2 generations on · 1 of its ownK173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with…Medical Components, Inc. (dba MedComp) · 2018
- Descendant · 2 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 3 of 3 · See all- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · cites it directly2descendants
- K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp) · 2018 · 2 generations on1descendant
- K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K974236 | Medcomp Schon XL Soft-Line Double Lumen Catheter, 15CM SBF146, Medcomp Schon… | Medical Components, Inc. | 1999 | — |
| −5 | K991320 | Medcomp Duo-Flow II Catheter with Lubricious Heparin | Medical Components, Inc. | 1999 | — |
| −4 | K060509 | Palindrome Emerald 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating | Tyco Healthcare Group | 2006 | 4 |
| −3 | K062671 | 14.5 FR Chronic Hemodialysis Catheter with Heparin Coating and Silver… | Kendall | 2006 | 24 |
| −2 | 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 |
| 0 (this device) | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
| +1 | K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017 | — |
| +2 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X… | Medical Components, Inc. (dba MedComp) | 2018 | — |
| +2 | 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 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K102043 | Ultrastream Chronic Hemodialysis CatheterSummary page 4…oduct Code: MSD Regulatory Class: II (Special Controls) Classification Panel: Gastroenterology and Urology 3. Predicate Devices’ Information: 1) K102043 - Rex Medical UltraStream Chronic Hemodialysis Catheter 2) K123196 - Palindrome™ Precision Symmetric Tip Lumen Catheter 4.… | 2010 |
| * | K123196 | Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter…Summary page 4…assification Panel: Gastroenterology and Urology 3. Predicate Devices’ Information: 1) K102043 - Rex Medical UltraStream Chronic Hemodialysis Catheter 2) K123196 - Palindrome™ Precision Symmetric Tip Lumen Catheter 4. Device Description: The Symetrex Long Term Hemodialysis Catheter… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171618 | Symetrex Long Term Hemodialysis Catheter | 2017 | 2 |
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.
- K123196Palindrome Precision H Chronic Catheter, Palindrome Precision SI Chronic Catheter, Palindrome Precision Hsi…Covidien · 2013 · Direct predicate · ◆ on the line of descent in FIG. 14 Class I recalls
- K112477Palindrome H, SI, Hsi Chronic CatheterCovidien · 2011 · 2 generations back · ◆ 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 · 2 generations back · ◆ in the 2011 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 15 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 12 of the 20 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K171618 (Medcomp (Dba Medical Components, Inc.), 2017) has gone furthest, with 2 descendants of its own.
How does its category compare?
All MSD devicesMSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Symetrex Long Term Hemodialysis Catheter is a symmetric tip dual lumen catheter designed
for chronic hemodialysis and apheresis. It may be inserted percutaneously or by cut down.
Catheters with greater than 37cm implant length are indicated for femoral placement.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140884 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140884: Symetrex Long Term Hemodialysis Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140884
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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