510(k) · Cleared
ClearedArrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow International, LLC (A subsidiary of Teleflex, Inc.) · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Mar 14, 2025 as substantially equivalent to K163513 (Arrow International, Inc. (Subsidiary of Teleflex, Inc.), 2017) after a 113-day review. Its family tree reaches back 5 generations to 1981. 4 of the 8 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 14, 2025
- Review
- 113 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K810675 (1981). 7 ancestors in all. No later device cites it as a predicate yet. 4 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK810675 Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · Recalled (Class I)
- 4 generations backK021120 Radial Artery Catherization Set with Integral Needle…Arrow Intl., Inc. · 2002 · Recalled (Class I)
- 3 generations backK151513 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow Internation, Inc. (Subsidiary of Teleflex Inc.) · 2015 · Recalled
- 2 generations backK152272 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2015
- 1 generation backK163513 Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · Recalled (Class I)
- This deviceK243599 Arrow™ Endurance™ Extended Dwell Peripheral Catheter System…Arrow International, LLC (A subsidiary of Teleflex, Inc.) · 2025
Class I recalls in this family
- K163513 Arrow Endurance Extended Dwell Peripheral…direct predicate · 2017
- K021120 Radial Artery Catherization Set with Integral…3 generations back · 2002
- K003006 Two-Lumen Picc with Blue Flextip Catheter and…4 generations back · 2000
- K810675 Arrow Radial Artery Catheterization Set4 generations back · 1981
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K810675 | Arrow Radial Artery Catheterization Set | Arrow Intl., Inc. | 1981 | Class I |
| −4 | K021120 | Radial Artery Catherization Set with Integral Needle Protection,Model… | Arrow Intl., Inc. | 2002 | Class I |
| −3 | K151513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow Internation, Inc. (Subsidiary of Teleflex Inc.) | 2015 | 1 |
| −2 | K152272 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2015 | — |
| −1 | K163513 | Arrow Endurance Extended Dwell Peripheral Catheter System | Arrow International, Inc. (Subsidiary of Teleflex, Inc.) | 2017 | Class I |
| 0 (this device) | K243599 | Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) | Arrow International, LLC (A subsidiary of Teleflex, Inc.) | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 1 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K163513 | Arrow Endurance Extended Dwell Peripheral Catheter SystemSummary page 5…avascular Catheter Classification Name: Catheter, intravascular, therapeutic, short-term less than 30 days (Class II, FOZ, 21 CFR 880.5200) 3. Predicate Device K163513: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System Common Name: Intravascular Catheter Classification Nam… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
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.
- K163513Arrow Endurance Extended Dwell Peripheral Catheter SystemArrow International, Inc. (Subsidiary of Teleflex, Inc.) · 2017 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K021120Radial Artery Catherization Set with Integral Needle Protection,Model RA-04020-SPArrow Intl., Inc. · 2002 · 3 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 · 4 generations back · ◆ in the 2000 ancestors bar of FIG. 11 Class I recall
- K810675Arrow Radial Artery Catheterization SetArrow Intl., Inc. · 1981 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 44 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- 6 of the 7 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K163513.
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. 2025, 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™ Extended Dwell Peripheral Catheter System permits access to the patient’s peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi. The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient’s peripheral vascular system for short-term use (less than 30 days) to facilitate…
Read the full statement (129 words)
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient’s peripheral vascular system for short-term venous use (less than 30 days) to sample blood, administer fluids, and perform high pressure contrast injections at a maximum of 325 psi.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter System permits access to the patient’s peripheral vascular system for short-term use (less than 30 days) to facilitate arterial blood pressure measurement and blood sampling.
The safety feature is intended to minimize the risk of sharps injuries.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used for any patient population with consideration given to adequacy of anatomy and appropriateness of the procedure.
The Arrow™ Endurance™ Extended Dwell Peripheral Catheter may be used in hospitals, clinics, and other advanced clinical facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243599 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243599: Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243599
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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