510(k) · Cleared
Recalled · Class II · 2014Ultrastream Chronic Hemodialysis Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rex Medical · MSD Catheter, Hemodialysis, Implanted
Cleared on Nov 18, 2010 as substantially equivalent to K071422 (Rex Medical, 2007) after a 121-day review. Its family tree reaches back 3 generations to 2001. 4 later devices descend from it. It has been recalled 3 times.
- Decided
- Nov 18, 2010
- Review
- 121 days
- Class
- Class II
- Product code
- MSD
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 3 generations to K012365 (2001). 4 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK012365 Vaxcel Dialysis CatheterBoston Scientific Corp · 2001
- 2 generations backK023847 Hemo-Stream Hemodialysis Catheter SetRex Medical · 2003 · Recalled
- 1 generation backK071422 15.5F Hemo-Stream Hemodialysis Catheter SetRex Medical · 2007
- This deviceK102043 Ultrastream Chronic Hemodialysis CatheterRex Medical · 2010
- Descendant · cites it directly · 3 of its ownK140884 Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014
- Descendant · 2 generations on · 2 of its ownK171618 Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017
- Descendant · 3 generations on · 1 of its ownK173667 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with…Medical Components, Inc. (dba MedComp) · 2018
- Descendant · 3 generations on · 0 of its ownK202176 Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020
Most influential descendants
Showing 4 of 4 · See all- K140884Symetrex Long Term Hemodialysis CatheterPhase One Medical · 2014 · cites it directly3descendants
- K171618Symetrex Long Term Hemodialysis CatheterMedcomp (Dba Medical Components, Inc.) · 2017 · 2 generations on2descendants
- K17366715.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm…Medical Components, Inc. (dba MedComp) · 2018 · 3 generations on1descendant
- K202176Symetrex LTHD Catheter, Symetrex LTHD Catheter with SideholesMedical Components, Inc. (dba MedComp) · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K012365 | Vaxcel Dialysis Catheter | Boston Scientific Corp | 2001 | — |
| −2 | K023847 | Hemo-Stream Hemodialysis Catheter Set | Rex Medical | 2003 | 3 |
| −1 | K071422 | 15.5F Hemo-Stream Hemodialysis Catheter Set | Rex Medical | 2007 | — |
| 0 (this device) | K102043 | Ultrastream Chronic Hemodialysis Catheter | Rex Medical | 2010 | — |
| +1 | K140884 | Symetrex Long Term Hemodialysis Catheter | Phase One Medical | 2014 | — |
| +2 | K171618 | Symetrex Long Term Hemodialysis Catheter | Medcomp (Dba Medical Components, Inc.) | 2017 | — |
| +3 | K173667 | 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X… | Medical Components, Inc. (dba MedComp) | 2018 | — |
| +3 | 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 |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
Planning a device in MSD? 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? (1)
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 |
|---|---|---|---|
| * | K071422 | 15.5F Hemo-Stream Hemodialysis Catheter SetSummary page 1…anager Date Summary Prepared: July 6, 201 0 2. Name of the Device: UltraStreamn Chronic Hemodialysis Catheter 3. Predicate Device Information: 1) K071422, Hemo-StreaMmT True Qver the Wire Dialysis Catheter 4. Device Description: The Rex Medical UltraStream Chronic Hemodialy… | 2007 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140884 | Symetrex Long Term Hemodialysis Catheter | 2014 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 5, 2014 | Class II | Z-2698-2014 | Component design/selection | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. |
| Jun 5, 2014 | Class II | Z-2696-2014 | Component design/selection | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. |
| Jun 5, 2014 | Class II | Z-2697-2014 | Component design/selection | UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K140884 (Phase One Medical, 2014) has gone furthest, with 3 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. 2010, 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 UltraStreamn Chronic Hemnodialysis Catheter is designed for chronic hemodialysis and apheresis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102043 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102043: Ultrastream Chronic 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/K102043
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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