510(k) · Cleared
Recalled · Class I · 2026Arrow Radial Artery Catheterization Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Intl., Inc. · DQX Wire, Guide, Catheter
Cleared on Mar 27, 1981 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 of the 64 devices in its family, counting itself, have a Class I recall. 63 later devices descend from it. It has been recalled 32 times, including a Class I recall.
- Decided
- Mar 27, 1981
- Review
- 15 days
- Class
- Class II
- Product code
- DQX
- Recalls
- 32 (1 Class I)
- Predicates
- 0
63 later devices descend from it, 9 citing it directly. 5 of the 64 devices in this family, counting this one, have a Class I recall.
- This deviceK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981
- Descendant · cites it directly · 44 of its ownK962746 Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996
- Descendant · 2 generations on · 41 of its ownK082644 GlidesheathTerumo Medical Corp. · 2008
- Descendant · 3 generations on · 17 of its ownK102008 GlidesheathTerumo Medical Corp. · 2010 · Recalled
- Descendant · 3 generations on · 12 of its ownK122980 Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model…Terumo Medical Corporation · 2012
- Descendant · 4 generations on · 8 of its ownK142183 Glidesheath SlenderTerumo Medical Corporation · 2014 · Recalled
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
1996high 9 (2018) · low 0 (2001)2026
Class I recalls in this family
- K021120 Radial Artery Catherization Set with Integral…cites it directly · 2002
- K160018 Arrow Quickflash Arterial Catheterization Devicecites it directly · 2016
- K171146 Arrow Seldinger Arterial Catheterization Device…2 generations on · 2017
- K163513 Arrow Endurance Extended Dwell Peripheral…3 generations on · 2017
Most influential descendants
Showing 5 of 63 · See all- K962746Cordis Avanti Trans-Radial Catheter Sheath Introducer KitCordis Corp. · 1996 · cites it directly44descendants
- K082644GlidesheathTerumo Medical Corp. · 2008 · 2 generations on41descendants
- K102008GlidesheathTerumo Medical Corp. · 2010 · 3 generations on17descendants
- K122980Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM* ES6F16HQ…Terumo Medical Corporation · 2012 · 3 generations on12descendants
- K142183Glidesheath SlenderTerumo Medical Corporation · 2014 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | 1981 | — |
| +1 | K962746 | Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit | Cordis Corp. | 1996 | — |
| +2 | K082644 | Glidesheath | Terumo Medical Corp. | 2008 | — |
| +3 | K102008 | Glidesheath | Terumo Medical Corp. | 2010 | 1 |
| +3 | K122980 | Glidesheath Slender Model RM* ES6J10HQS, Glidesheath Slender Model RM*… | Terumo Medical Corporation | 2012 | — |
| +4 | K142183 | Glidesheath Slender | Terumo Medical Corporation | 2014 | 17 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 2 | 1 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 2 | 0 |
| 2014 | 7 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 1 |
| 2017 | 5 | 2 |
| 2018 | 9 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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.
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 DQX device
- #1 K213854 SavvyWirescore 15.7 · 10 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? (63)
See all 639 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962746 | Cordis Avanti Trans-Radial Catheter Sheath Introducer Kit | 1996 | 44 |
| K021120 | Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SP Class I | 2002 | 7 |
| K093050 | Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520 | 2009 | 3 |
| K160448 | Artline | 2016 | 1 |
| K991886 | Pulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate Sensor | 2000 | 1 |
| K980504 | Emcee Introducer Sheath, Dilator, Obturator, Introducer Set | 1998 | 1 |
| K210548 | Medline Integrated Arterial Catheter | 2022 | 0 |
| K160018 | Arrow Quickflash Arterial Catheterization Device Class I | 2016 | 0 |
| K971086 | Radial and Femoral Artery Catheter | 1997 | 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-2397-2026 | 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… |
| Jul 26, 2024 | Class II | Z-3299-2024 | Nonconforming Material/Component | Reports have been received regarding open seals on the packaging. |
| Dec 12, 2019 | Class II | Z-0844-2020 | Labeling Change Control | The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit |
| Apr 11, 2018 | Class II | Z-1972-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1969-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1970-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1971-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-1968-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Apr 11, 2018 | Class II | Z-2019-2018 | Under Investigation by firm | Product sterility may be compromised due to unsealed packaging. |
| Dec 22, 2017 | Class II | Z-1330-2018 | Process control | Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. |
| Oct 26, 2017 | Class II | Z-1286-2018 | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Oct 26, 2017 | Class II | Z-1281-2018 | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Oct 26, 2017 | Class II | Z-1285-2018 | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Oct 26, 2017 | Class II | Z-1283-2018 | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Oct 26, 2017 | Class II | Z-1284-2018 | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Oct 26, 2017 | Class II | Z-1282-2018 | Nonconforming Material/Component | The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life. |
| Jul 10, 2017 | Class II | Z-0486-2018 | Material/Component Contamination | Needle supplier indicated the presence of loose polypropylene foreign matter above release specification. |
| May 9, 2017 | Class II | Z-2327-2017 | Packaging | Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility. |
| Aug 8, 2016 | Class II | Z-2740-2016 | Process control | Shipping carton labeling error. |
| Aug 8, 2016 | Class II | Z-2741-2016 | Process control | Shipping carton labeling error. |
| Jun 2, 2016 | Class II | Z-2202-2016 | Labeling mix-ups | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. |
| Jun 2, 2016 | Class II | Z-2201-2016 | Labeling mix-ups | Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits. |
| 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. |
| Oct 29, 2010 | Not classified | Z-1356-2011 | Other | Sterility may be compromised. |
| Oct 29, 2010 | Not classified | Z-1359-2011 | Other | Sterility may be compromised. |
| Oct 29, 2010 | Not classified | Z-1346-2011 | Other | Sterility may be compromised. |
| Oct 29, 2010 | Not classified | Z-1360-2011 | Other | Sterility may be compromised. |
| Oct 29, 2010 | Not classified | Z-1357-2011 | Other | Sterility may be compromised. |
| Oct 29, 2010 | Not classified | Z-1358-2011 | Other | Sterility may be compromised. |
| Oct 29, 2010 | Not classified | Z-1355-2011 | Other | Sterility may be compromised. |
| Jul 29, 2010 | Not classified | Z-2494-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
| Jul 29, 2010 | Not classified | Z-2495-2010 | Mixed-up of materials/components | Incorrectly assembled 18 Ga x 2 1/2 Introducer Needle |
The 5 latest of 32 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.
- K021120Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPArrow Intl., Inc. · 2002 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K160018Arrow Quickflash Arterial Catheterization DeviceArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2016 · Cites it directly · ◆ in the 2016 descendants bar of FIG. 12 Class I recalls
- K171146Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
- K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · 3 generations on · ◆ in the 2017 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K962746 (Cordis Corp., 1996) has gone furthest, with 44 descendants of its own.
How does its category compare?
All DQX devicesDQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQX
10in 2025
2007high 21 (2010) · low 6 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · DQX
177in 2025
2007high 212 (2022) · low 43 (2011)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQX
3in 2024
2007high 49 (2009) · low 0 (2014)2026
Class I (8 since 2007) Class II/III not classified
Adverse event reports per year · DQX
2,178in 2025
2007high 2,210 (2024) · low 687 (2009)2025
MAUDE reports naming product code DQX, 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 | 14 | 85 | 12 | 760 |
| 2008 | 19 | 87 | 7 | 715 |
| 2009 | 18 | 87 | 49 | 687 |
| 2010 | 21 | 63 | 34 | 987 |
| 2011 | 18 | 43 | 3 | 1,311 |
| 2012 | 20 | 62 | 5 | 1,337 |
| 2013 | 18 | 119 | 7 (4) | 1,474 |
| 2014 | 18 | 103 | 0 | 1,323 |
| 2015 | 15 | 112 | 1 | 1,323 |
| 2016 | 14 | 179 | 2 (2) | 1,466 |
| 2017 | 19 | 85 | 17 | 1,524 |
| 2018 | 19 | 114 | 9 | 1,737 |
| 2019 | 13 | 173 | 2 | 1,679 |
| 2020 | 14 | 106 | 1 (1) | 1,536 |
| 2021 | 6 | 161 | 0 | 1,713 |
| 2022 | 15 | 212 | 0 | 1,647 |
| 2023 | 10 | 136 | 0 | 2,068 |
| 2024 | 11 | 134 | 3 | 2,210 |
| 2025 | 10 | 177 | 0 | 2,178 |
| 2026 | 12 | 145 | 4 (1) | — |
https://510kreport.com/device/K810675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K810675: Arrow Radial Artery Catheterization Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810675
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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