510(k) · Cleared
Recalled · Class I · 202614 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · MPB Catheter, Hemodialysis, Non-Implanted
Cleared on Sep 14, 2000 as substantially equivalent to K900263 (Arrow Intl., Inc., 1990) and 1 other predicate after a 301-day review. Its family tree reaches back 1 generation to 1990. 5 of the 11 devices in its family, counting itself, have a Class I recall. 8 later devices descend from it. It has been recalled 5 times, including a Class I recall.
- Decided
- Sep 14, 2000
- Review
- 301 days
- Class
- Class II
- Product code
- MPB
- Recalls
- 5 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 1 generation to K895417 (1990). 2 ancestors in all. 8 later devices descend from it, 5 citing it directly. 5 of the 11 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK895417 Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · Recalled (Class I)
- This deviceK993933 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip…Arrow Intl., Inc. · 2000
- Descendant · cites it directly · 1 of its ownK122091 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum…Cook, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK053589 Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial…Arrow Intl., Inc. · 2001 · Recalled (Class I)
- Descendant · 2 generations on · 0 of its ownK161504 Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated · 2017
- Descendant · cites it directly · 0 of its ownK143102 Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · Recalled (Class I)
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K900263 Antimicrobial Multi-Lumen Central Venous Catheterdirect predicate · 1990
- K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kitdirect predicate · 1990
- K143102 Multi-Lumen Acute Hemodialysis Catheter for High…cites it directly · 2015
- K011761 Mac Two-Lumen Central Venous Kit with Arrowg Ard…cites it directly · 2001
Most influential descendants
Showing 5 of 8 · See all- K122091Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute…Cook, Inc. · 2013 · cites it directly1descendant
- K053589Long-Term Hemodialysis Catheters with Biobloc CoatingBard Access Systems, Inc. · 2006 · cites it directly1descendant
- K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral…Arrow Intl., Inc. · 2001 · cites it directly1descendant
- K161504Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/TrayCook Incorporated · 2017 · 2 generations on0descendants
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K895417 | Arrow Large-Bore Dual Lumen Hemodialysis Kit | Arrow Intl., Inc. | 1990 | Class I |
| 0 (this device) | K993933 | 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard… | Arrow Intl., Inc. | 2000 | — |
| +1 | K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo… | Cook, Inc. | 2013 | — |
| +1 | K053589 | Long-Term Hemodialysis Catheters with Biobloc Coating | Bard Access Systems, Inc. | 2006 | — |
| +1 | K011761 | Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface… | Arrow Intl., Inc. | 2001 | Class I |
| +2 | K161504 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray | Cook Incorporated | 2017 | — |
| +1 | K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 1 |
| 2003 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 1 |
| 2017 | 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.
5 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 MPB device
- #1 K250836 14F Duo-Flow® Side X Side Double Lumen Catheterscore 10.1 · 2 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 |
|---|---|---|---|
| * | K900263 | Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…0, Catheter, Hemodialysis, non-implanted Legally marketed devices to which the device is substantially equivalent: « Antimicrobial multi-lumen central venous catheter (K900263) * Arrow large-bore dual lumen hemodialysis kit (K895417) Description of device: The materials, construction, and manufacturing… | 1990 |
| * | K895417 | Arrow Large-Bore Dual Lumen Hemodialysis KitSummary page 1…d devices to which the device is substantially equivalent: « Antimicrobial multi-lumen central venous catheter (K900263) * Arrow large-bore dual lumen hemodialysis kit (K895417) Description of device: The materials, construction, and manufacturing processes of both the legally marketed 12 Fr Hemodialysi… | 1990 |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122091 | Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray Cook Spectrum Turbo-Flo HD Acute… | 2013 | 1 |
| K053589 | Long-Term Hemodialysis Catheters with Biobloc Coating | 2006 | 1 |
| K011761 | Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral… Class I | 2001 | 1 |
| K143102 | Multi-Lumen Acute Hemodialysis Catheter for High Volume Infusions Class I | 2015 | 0 |
| K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters | 2006 | 0 |
Has anything in its family been recalled? (5 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2373-2026 | 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-1336-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| Oct 17, 2017 | Class II | Z-0658-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| May 9, 2017 | Class II | Z-2334-2017 | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Feb 18, 2004 | Not classified | Z-0639-04 | Other | catheter slips out of the suture wing during use. |
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.
- K900263Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 1990 · Direct predicate · ◆ in the 1990 ancestors bar of FIG. 12 Class I recalls
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · Cites it directly · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K011761Mac Two-Lumen Central Venous Kit with Arrowg Ard Blue Antimicrobial Surface and Integral Hemostasis…Arrow Intl., Inc. · 2001 · Cites it directly · ◆ in the 2001 descendants bar of FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All MPB devicesMPB Catheter, Hemodialysis, Non-Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MPB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MPB
205in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MPB
4so far in 2026, the most since 2007
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · MPB
187in 2025
MAUDE reports naming product code MPB, 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 | 3 | 136 | 1 | 41 |
| 2008 | 0 | — | 0 | 147 |
| 2009 | 1 | — | 0 | 166 |
| 2010 | 1 | — | 0 | 60 |
| 2011 | 2 | — | 0 | 74 |
| 2012 | 1 | — | 0 | 78 |
| 2013 | 1 | — | 0 | 124 |
| 2014 | 0 | — | 0 | 82 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 1 | — | 0 | 70 |
| 2017 | 2 | — | 2 | 86 |
| 2018 | 0 | — | 0 | 120 |
| 2019 | 0 | — | 0 | 119 |
| 2020 | 3 | 205 | 0 | 179 |
| 2021 | 0 | — | 0 | 192 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 203 |
| 2024 | 0 | — | 0 | 181 |
| 2025 | 1 | — | 0 | 187 |
| 2026 | 0 | — | 4 (3) | — |
What is it indicated for?
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins The ARROWg+ard Blue® antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the…
Read the full statement (107 words)
The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid administration, temporary or acute hemodialysis, apheresis and hemofiltration. It may be inserted into the jugular, subclavian, or femoral veins
The ARROWg+ard Blue® antimicrobial surface catheter helps provide protection against catheter-related infections resulting from microorganisms migrating the subcutaneous tract along the exterior surface of the catheter when used for infusion. Clinical data have not been collected that demonstrate the use of the ARROWg+ard Blue® antimicrobial surface in decreasing catheter-related infections in hemodialysis patients. The catheter is not intended to be used as a treatment for existing mfectlons, nor is it indicated for long-term use.
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/K993933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993933: 14 FR Two-Lumen Hemodialysis Catherization Kit with Blue Flextip Arrowg+Ard Blue Catheter for High Volume Infusions, Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993933
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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