510(k) · Cleared
ClearedMerit RadialFlo Arterial Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Merit Medical Singapore Pte., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jan 16, 2019 as substantially equivalent to K151698 (Becton Dickinson Infusion Therapy Systems, Inc., 2015) after a 124-day review. Its family tree reaches back 2 generations to 2001.
- Decided
- Jan 16, 2019
- Review
- 124 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013800 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK013800 Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard…Becton Dickinson Infusion Therapy Systems, Inc. · 2001
- 1 generation backK151698 BD Angiocath IV Catheter, BD Insyte IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. · 2015
- This deviceK182538 Merit RadialFlo Arterial CatheterMerit Medical Singapore Pte., Ltd. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013800 | Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro… | Becton Dickinson Infusion Therapy Systems, Inc. | 2001 | — |
| −1 | K151698 | BD Angiocath IV Catheter, BD Insyte IV Catheter | Becton Dickinson Infusion Therapy Systems, Inc. | 2015 | — |
| 0 (this device) | K182538 | Merit RadialFlo Arterial Catheter | Merit Medical Singapore Pte., Ltd. | 2019 | — |
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.
Planning a device in FOZ? 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 13.6 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K151698.
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. 2019, 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 Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182538 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182538: Merit RadialFlo Arterial Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182538
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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