510(k) · Cleared
Recalled · Class I · 2026Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. (Subsidiary of Telelflex Inc.) · DQY Catheter, Percutaneous
Cleared on Jun 23, 2017 as substantially equivalent to K093050 (Arrow Intl., Inc., 2009) after a 65-day review. Its family tree reaches back 2 generations to 1981. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Jun 23, 2017
- Review
- 65 days
- Class
- Class II
- Product code
- DQY
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K810675 (1981). 2 later devices descend from it, 2 citing it directly. 2 of the 5 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
- 1 generation backK093050 Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
- This deviceK171146 Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow…Arrow International, Inc. (Subsidiary of Telelflex Inc.) · 2017
- Descendant · cites it directly · 0 of its ownK201726 Arterial CatheterHaolang Medical USA Corporation · 2021
- Descendant · cites it directly · 0 of its ownK181563 The ARTERIAL WAND Safety Introducer with Arterial Catheter made of…Access Scientific, LLC · 2018
Class I recalls in this family
- K810675 Arrow Radial Artery Catheterization Set2 generations back · 1981
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | 1981 | Class I |
| −1 | K093050 | Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520 | Arrow Intl., Inc. | 2009 | — |
| 0 (this device) | K171146 | Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger… | Arrow International, Inc. (Subsidiary of Telelflex Inc.) | 2017 | — |
| +1 | K201726 | Arterial Catheter | Haolang Medical USA Corporation | 2021 | — |
| +1 | K181563 | The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex… | Access Scientific, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2021 | 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.
2 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? (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 |
|---|---|---|---|
| * | K093050 | Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Summary page 4…Common Name: Percutaneous Arterial Catheter Classification Name: Catheter, percutaneous (Class II, DQY, 21 CFR 870.1250) 3. Predicate Devices K093050: Arrow Seldinger Arterial Catheterization Devices 4. Device Description The subject Arrow Seldinger Arterial Catheterization… | 2009 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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… |
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.
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 36 years and passes through 2 companies; a new generation was cleared every 28.7 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- Of its descendants, K201726 (Haolang Medical USA Corporation, 2021) has gone furthest, with 0 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. 2017, this device’s year, is highlighted.
FDA decisions per year · DQY
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQY
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQY
1in 2025
Class I (10 since 2007) Class II/III not classified
Adverse event reports per year · DQY
3,056in 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) | — |
What is it indicated for?
The Arrow Seldinger Arterial Catheterization Devices permit access to the peripheral arterial circulation or to other small vessels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171146: Arrow Seldinger Arterial Catheterization Device 18 ga., Arrow Seldinger Arterial Catheterization Device 20 ga., Arrow Seldinger Arterial Catheterization Device 22 ga., Arrow Seldinger Arterial Catheterization Device 24 ga..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171146
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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