510(k) · Decided
Recalled · Class I · 2026Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · NIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted
Cleared on Jul 24, 2015 as substantially equivalent to K993933 (Arrow Intl., Inc., 2000) and 2 other predicates after a 268-day review. Its family tree reaches back 8 generations to 2000. 7 of the 29 devices in its family, counting itself, have a Class I recall. It has been recalled 2 times, including a Class I recall.
- Decided
- Jul 24, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- NIE
- Recalls
- 2 (1 Class I)
- Predicates
- 3
Its longest line of descent runs back 8 generations to K001901 (2000). 28 ancestors in all, the oldest K830256 (1983). No later device cites it as a predicate yet. 7 of the 29 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK033389 Powerpicc Catheters, Models 3175155, 3175135C.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050185 Powerhohn and Powerline CathetersC.R. Bard, Inc. · 2005
- 3 generations backK051417 6 FR FL Powerhohn and Powerline CatheterC.R. Bard, Inc. · 2005 · Recalled
- 2 generations backK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- 1 generation backK083675 Power-Trialysis Triple Lumen Acute Dialysis CatheterC.R. Bard, Inc. · 2009
- This deviceK143102 Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015
Class I recalls in this family
- K993933 14 FR Two-Lumen Hemodialysis Catherization Kit…direct predicate · 2000
- K020089 Mahurkar Triple Lumen Catheter, 12 FR2 generations back · 2002
- K900263 Antimicrobial Multi-Lumen Central Venous Catheter2 generations back · 1990
- K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kit2 generations back · 1990
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K033389 | Powerpicc Catheters, Models 3175155, 3175135 | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050185 | Powerhohn and Powerline Catheters | C.R. Bard, Inc. | 2005 | — |
| −3 | K051417 | 6 FR FL Powerhohn and Powerline Catheter | C.R. Bard, Inc. | 2005 | 1 |
| −2 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| −1 | K083675 | Power-Trialysis Triple Lumen Acute Dialysis Catheter | C.R. Bard, Inc. | 2009 | — |
| 0 (this device) | K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 1 |
| 1990 | 2 | 2 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 2 |
| 2001 | 3 | 0 |
| 2002 | 1 | 1 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 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.
7 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 NIE device
- #1 K232945 Trio-CT® Triple Lumen Catheter w/ Curved…score 9.4 · 11 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue…Summary page 5…ate 1: 12 Fr. and 14 Fr. Two-Lumen Hemodialysis Catheterization Kit with Blue FlexTip® ARROWg+ard Blue® Antimicrobial Catheter for High Volume Infusions (K993933) Predicate 2: Bard Power-TrialysisTM Short Term Dialysis Catheter (K083675) Predicate 3: Medcomp Tri-Flow® Triple Lumen Sho… | 2000 |
| * | K083675 | Power-Trialysis Triple Lumen Acute Dialysis CatheterSummary page 5…FlexTip® ARROWg+ard Blue® Antimicrobial Catheter for High Volume Infusions (K993933) Predicate 2: Bard Power-TrialysisTM Short Term Dialysis Catheter (K083675) Predicate 3: Medcomp Tri-Flow® Triple Lumen Short Term Hemodialysis Catheter (K973561) 4. Device Description The Multi… | 2009 |
| * | K973561 | Medcomp Tri-Flow Soft Tip Triple Lumen Catheter 11.5F X 12CM, Medcomp Tri-Flow Soft Tip…Summary page 5…993933) Predicate 2: Bard Power-TrialysisTM Short Term Dialysis Catheter (K083675) Predicate 3: Medcomp Tri-Flow® Triple Lumen Short Term Hemodialysis Catheter (K973561) 4. Device Description The Multi-Lumen Acute Hemodialysis Catheter for High Volume (hereafter referred to as the 3-L AHDC)… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2374-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Dec 22, 2017 | Class II | Z-1328-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
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.
- K99393314 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume…Arrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K020089Mahurkar Triple Lumen Catheter, 12 FRThe Kendall Company · 2002 · 2 generations back · ◆ in the 2002 ancestors bar of FIG. 125 Class I recalls
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 2 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
Nearest 5 of 6; all are on the web page.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 14 of the 28 ancestors have a recall of any class; 6 have a Class I recall.
- 4 other devices also cite its predicate K993933.
How does its category compare?
All NIE devicesNIE Catheter, Hemodialysis, Triple Lumen, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NIE
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NIE
Too few NIE 510(k)s in any year since 2007 to give a median.
Recalls per year · NIE
6in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · NIE
72in 2025
MAUDE reports naming product code NIE, 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 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 1 | — | 0 | 7 |
| 2014 | 1 | — | 0 | 13 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 13 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 1 | — | 0 | 88 |
| 2019 | 1 | — | 1 | 61 |
| 2020 | 0 | — | 0 | 51 |
| 2021 | 0 | — | 0 | 61 |
| 2022 | 0 | — | 1 (1) | 119 |
| 2023 | 2 | — | 0 | 103 |
| 2024 | 0 | — | 0 | 125 |
| 2025 | 0 | — | 6 | 72 |
| 2026 | 0 | — | 3 (1) | — |
What is it indicated for?
The device is indicated for use in attaining short-term (less than 30 days) vascular access for hemodialysis, apheresis, rapid fluid administration, intravenous therapy, blood sampling, pressure injection of contrast media, and central venous pressure monitoring. The catheter may also be used in a variety of renal replacement therapies, such as hemofiltration and hemoperfusion. The catheter may be inserted into the jugular, subclavian, or femoral veins. The maximum pressure injection flow rate is 6 mL / sec.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143102: Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143102
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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