510(k) · Cleared
Recalled · Class I · 2026[Central Venous][Multi-Lumen] Catheter W/Flex Tip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DQY Catheter, Percutaneous
Cleared on Aug 25, 1986 after an 87-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 17 of the 152 devices in its family, counting itself, have a Class I recall. 151 later devices descend from it. It has been recalled 24 times, including a Class I recall.
- Decided
- Aug 25, 1986
- Review
- 87 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 24 (1 Class I)
- Predicates
- 0
151 later devices descend from it, 3 citing it directly. 17 of the 152 devices in this family, counting this one, have a Class I recall.
- This deviceK862056 [Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986
- Descendant · cites it directly · 136 of its ownK992198 Urethane Picc Line Model Upics-Cook, Inc. · 1999
- Descendant · 2 generations on · 126 of its ownK021557 Spectrum Silicone CatheterCook, Inc. · 2003
- Descendant · 3 generations on · 119 of its ownK051991 Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and…C.R. Bard, Inc. · 2005
- Descendant · 4 generations on · 66 of its ownK070996 4 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007
- Descendant · 4 generations on · 47 of its ownK061179 Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006
Showing 5 of 151 descendants. See all descendants
Descendants cleared per year
1997high 17 (2012) · low 0 (1998)2026
Class I recalls in this family
- K970864 Arrow-Howes Large Bore Multi-Lumen Central…cites it directly · 1997
- K071538 Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus…cites it directly · 2007
- K132133 CG+ Arrow Jacc Powered by Arrow VPS Stylet3 generations on · 2013
- K153423 CG+ Arrow JACC powered by Arrow VPS Stylet, CG+…4 generations on · 2016
Most influential descendants
Showing 5 of 151 · See all- K992198Urethane Picc Line Model Upics-Cook, Inc. · 1999 · cites it directly136descendants
- K021557Spectrum Silicone CatheterCook, Inc. · 2003 · 2 generations on126descendants
- K051991Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power LineC.R. Bard, Inc. · 2005 · 3 generations on119descendants
- K0709964 FR Single Lumen (SL) Powerpicc CatheterC.R. Bard, Inc. · 2007 · 4 generations on66descendants
- K061179Powerhickman Long-Term Intravascular CatheterC.R. Bard, Inc. · 2006 · 4 generations on47descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K862056 | [Central Venous][Multi-Lumen] Catheter W/Flex Tip | Arrow Intl., Inc. | 1986 | — |
| +1 | K992198 | Urethane Picc Line Model Upics- | Cook, Inc. | 1999 | — |
| +2 | K021557 | Spectrum Silicone Catheter | Cook, Inc. | 2003 | — |
| +3 | K051991 | Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line | C.R. Bard, Inc. | 2005 | — |
| +4 | K070996 | 4 FR Single Lumen (SL) Powerpicc Catheter | C.R. Bard, Inc. | 2007 | — |
| +4 | K061179 | Powerhickman Long-Term Intravascular Catheter | C.R. Bard, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 1 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 1 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 9 | 1 |
| 2011 | 5 | 0 |
| 2012 | 17 | 3 |
| 2013 | 14 | 2 |
| 2014 | 14 | 2 |
| 2015 | 8 | 2 |
| 2016 | 16 | 2 |
| 2017 | 4 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 3 | 1 |
| 2022 | 4 | 1 |
| 2023 | 4 | 0 |
| 2025 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
17 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 DQY device
- #1 K234115 APRO 55 Catheterscore 17.5 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (151)
See all 1513 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (17 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2377-2026 | 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… |
| Jan 10, 2019 | Class II | Z-1118-2019 | Error in labeling | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct |
| Jan 10, 2019 | Class II | Z-1119-2019 | Error in labeling | The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct |
| Nov 14, 2018 | Class II | Z-0723-2019 | Error in labeling | The lidstock states the incorrect priming volume and flow rates. |
| Jul 10, 2018 | Class II | Z-2819-2018 | Under Investigation by firm | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. |
| Jul 10, 2018 | Class II | Z-2818-2018 | Under Investigation by firm | The packaging may not be sealed. If the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. |
| May 11, 2018 | Class II | Z-2336-2018 | Employee error | The recalling firm has received complaints related to increased resistance encountered when introducing the CVC over the spring wire guide. This may lead to procedural delay, and there may be need of medical intervention by exchanging the… |
| Apr 11, 2018 | Class II | Z-1982-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1978-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1967-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1332-2018 | 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-0648-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0652-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0657-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0650-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| Oct 17, 2017 | Class II | Z-0654-2018 | Process control | These finished good kits may contain the incorrect Springwire Guide (SWG). |
| May 9, 2017 | Class II | Z-2336-2017 | Packaging | The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited to: -multiple infusions of fluids, medications, or… |
| Sep 18, 2014 | Class II | Z-0076-2015 | Labeling False and Misleading | Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are… |
| Aug 6, 2014 | Class II | Z-0066-2015 | Packaging | The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility. |
| Jul 31, 2013 | Class II | Z-1965-2013 | Labeling Change Control | Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly identifies the catheter as 2-Lumen. |
| Nov 9, 2010 | Not classified | Z-0898-2011 | Process control | One lot of product was inadvertently mislabeled with a product lidstock identifying the product as a triple-lumen catheter with product number CV-15703, but a double-lumen catheter with part number CV-16702 was actually packaged in the kit. |
| Jun 17, 2009 | Not classified | Z-1653-2009 | Process design | The spring wire guide is too large in diameter to pass through the needle, dilator and catheter. |
| Feb 11, 2009 | Not classified | Z-1495-2009 | Device Design | Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism. |
| Sep 16, 2003 | Not classified | Z-0083-04 | Other | wrong product in box |
The 5 latest of 24 recalls; the web page lists all.
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.
- K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · Cites it directly · ◆ in the 1997 descendants bar of FIG. 11 Class I recall
- K071538Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous CatheterArrow International, Inc. · 2007 · Cites it directly · ◆ in the 2007 descendants bar of FIG. 15 Class I recalls
- K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.) · 2013 · 3 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall
- K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · 4 generations on · ◆ in the 2016 descendants bar of FIG. 11 Class I recall
- K210264BD PowerPiCC CatheterBard Access Systems, Inc. · 2021 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
- K113277Arrowadvantages Pressure Injectable Peripherally Inscrted Central Catheter KitsArrow International, Inc. · 2012 · 5 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K143102Multi-Lumen Acute Hemodialysis Catheter for High Volume InfusionsArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015 · 5 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
- K133456Power-Trialysis Short-Term Dialysis CatheterC.R. Bard, Inc. · 2014 · 5 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K102605Mahurkar Triple Lumen Dialysis CatheterCovidien, LLC, Formerly Registered AS Tyco Healthca · 2010 · 5 generations on · ◆ in the 2010 descendants bar of FIG. 125 Class I recalls
- K112896Arrw EvolutionArrow International (Subsidiary of Teleflex Inc.) · 2012 · 6 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
- K131260Nmi Dialysis CatheterNavilyst Medical, Inc. · 2014 · 6 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall
- K141531Power-Trialysis Slim-Cath Short-Term Dialysis CatheterC.R. Bard, Inc. · 2015 · 6 generations on · ◆ in the 2015 descendants bar of FIG. 11 Class I recall
Nearest 12 of 16 shown.
Nearest 5 of 16; all are on the web page.
What does this lineage say?
- Of its descendants, K992198 (Cook, Inc., 1999) has gone furthest, with 136 descendants of its own.
How does its category compare?
All DQY devicesDQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQY
21in 2025
2007high 37 (2009) · low 16 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
2007high 127 (2014) · low 66 (2008)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
2007high 36 (2013) · low 0 (2022)2026
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 2025
2007high 3,190 (2024) · low 313 (2007)2025
MAUDE reports naming product code DQY, 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 | 16 | 85 | 6 | 313 |
| 2008 | 31 | 66 | 12 | 496 |
| 2009 | 37 | 73 | 17 | 819 |
| 2010 | 22 | 74 | 32 | 1,293 |
| 2011 | 36 | 71 | 6 | 1,211 |
| 2012 | 30 | 87 | 2 | 1,191 |
| 2013 | 32 | 92 | 36 (1) | 1,352 |
| 2014 | 19 | 127 | 3 | 1,497 |
| 2015 | 27 | 118 | 3 | 2,337 |
| 2016 | 22 | 117 | 22 (7) | 2,252 |
| 2017 | 26 | 113 | 8 | 2,489 |
| 2018 | 25 | 106 | 2 | 2,855 |
| 2019 | 30 | 111 | 1 | 2,902 |
| 2020 | 20 | 120 | 2 | 2,889 |
| 2021 | 18 | 81 | 2 | 3,006 |
| 2022 | 18 | 74 | 0 | 2,643 |
| 2023 | 18 | 114 | 17 | 3,049 |
| 2024 | 16 | 87 | 1 | 3,190 |
| 2025 | 21 | 115 | 1 (1) | 3,056 |
| 2026 | 11 | 30 | 2 (1) | — |
https://510kreport.com/device/K862056 · printed Nov 6, 2026
Cite this page
510(k) Report. “K862056: [Central Venous][Multi-Lumen] Catheter W/Flex Tip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862056
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026