510(k) · Cleared
Recalled · Class I · 2023Arrow Endurance Extended Dwell Peripheral Catheter System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, Inc. (Subsidiary of Teleflex, Inc.) · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Feb 24, 2017 as substantially equivalent to K152272 (Arrow International, Inc. (Subsidiary of Teleflex, Inc.), 2015) and 1 other predicate after a 71-day review. Its family tree reaches back 4 generations to 1981. 4 of the 9 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Feb 24, 2017
- Review
- 71 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 2 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 4 generations to K810675 (1981). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly. 4 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 4 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
- 3 generations backK021120 Radial Artery Catherization Set with Integral Needle…Arrow Intl., Inc. · 2002 · Recalled (Class I)
- 2 generations backK151513 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) · 2015 · Recalled
- 1 generation backK152272 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015
- This deviceK163513 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017
- Descendant · cites it directly · 0 of its ownK243599 Arrow™ Endurance™ Extended Dwell Peripheral Catheter System…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2025
- Descendant · cites it directly · 0 of its ownK242281 Arrow Endurance Extended Dwell Peripheral Catheter System…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2024
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See all- K243599Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2025 · cites it directly0descendants
- K242281Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow Endurance…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | 1981 | Class I |
| −3 | K021120 | Radial Artery Catherization Set with Integral Needle Protection,Model… | Arrow Intl., Inc. | 2002 | Class I |
| −2 | K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | 2015 | 1 |
| −1 | K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015 | — |
| 0 (this device) | K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017 | — |
| +1 | K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025 | — |
| +1 | K242281 | Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620); Arrow… | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 1 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 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.
4 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 FOZ device
- #1 K243403 BD Nexiva™ Closed IV Catheter Systemscore 14.8 · 8 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 |
|---|---|---|---|
| * | K152272 | Arrow Endurance Extended Dwell Peripheral Catheter SystemSummary page 4…Peripheral Intravascular Catheter Classification Name: Catheter, intravascular, therapeutic (Class II, FOZ, 21 CFR 880.5200) 3. Predicate Devices K152272: Arrow® Endurance™ Extended Dwell Peripheral Catheter System K151513: Arrow® Endurance™ Extended Dwell Peripheral Cathete… | 2015 |
| * | K151513 | Arrow Endurance Extended Dwell Peripheral Catheter SystemSummary page 4…intravascular, therapeutic (Class II, FOZ, 21 CFR 880.5200) 3. Predicate Devices K152272: Arrow® Endurance™ Extended Dwell Peripheral Catheter System K151513: Arrow® Endurance™ Extended Dwell Peripheral Catheter System 4. Device Description The Arrow® Endurance™ Extended Dwell Perip… | 2015 |
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? (4 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2023 | Class I | Z-1826-2023 | Under Investigation by firm | Potential for catheter separation or leakage |
| Dec 6, 2019 | Class II | Z-0837-2020 | Employee error | Potential sterility issue for specific lots of the Arrow Endurance" Extended Dwell Peripheral Catheter System, Product Code ASK-00820-FLH. |
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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K003006Two-Lumen Picc with Blue Flextip Catheter and Integral Needle ProtectionArrow Intl., Inc. · 2000 · 3 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 3 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 3 companies; a new generation was cleared every 13.2 years on median.
- 5 of the 6 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K243599 (Arrow International, LLC (A subsidiary of Teleflex, Inc.), 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FOZ devicesFOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · FOZ
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FOZ
91in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FOZ
4in 2023
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · FOZ
5,110in 2025
MAUDE reports naming product code FOZ, 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 | 6 | 159 | 16 | 374 |
| 2008 | 9 | 103 | 0 | 422 |
| 2009 | 9 | 30 | 23 | 508 |
| 2010 | 3 | 28 | 115 | 370 |
| 2011 | 6 | 132 | 0 | 786 |
| 2012 | 13 | 122 | 0 | 560 |
| 2013 | 4 | 104 | 2 | 640 |
| 2014 | 9 | 99 | 4 | 815 |
| 2015 | 10 | 107 | 0 | 729 |
| 2016 | 9 | 63 | 3 (1) | 925 |
| 2017 | 9 | 51 | 22 | 1,966 |
| 2018 | 1 | — | 4 | 3,305 |
| 2019 | 8 | 140 | 3 | 4,365 |
| 2020 | 10 | 191 | 3 | 3,797 |
| 2021 | 4 | 242 | 1 | 4,674 |
| 2022 | 8 | 183 | 4 (2) | 4,133 |
| 2023 | 9 | 129 | 4 (2) | 4,430 |
| 2024 | 6 | 190 | 0 | 4,772 |
| 2025 | 11 | 91 | 0 | 5,110 |
| 2026 | 7 | 203 | 2 | — |
What is it indicated for?
The ARROW Endurance catheter system permits access to the patient’s peripheral vascular system for short-term use to sample blood, monitor blood pressure, or administer fluids. The catheter may be used for high pressure injection. The safety feature is intended to minimize the risk of sharps injuries.
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/K163513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163513: Arrow Endurance Extended Dwell Peripheral Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163513
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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