510(k) · Cleared
ClearedSURFLO Hybria Closed System Safety IV Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Products (Hangzhou) Co., Ltd. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Dec 17, 2025 as substantially equivalent to K102520 (Becton Dickinson Infusion Therapy Systems, Inc., 2011) after a 139-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Dec 17, 2025
- Review
- 139 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032843 (2004). No later device cites it as a predicate yet.
- Root · 2 generations backK032843 Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2004 · Recalled
- 1 generation backK102520 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2011
- This deviceK252398 SURFLO Hybria Closed System Safety IV CatheterTerumo Medical Products (Hangzhou) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032843 | Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2004 | 17 |
| −1 | K102520 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2011 | — |
| 0 (this device) | K252398 | SURFLO Hybria Closed System Safety IV Catheter | Terumo Medical Products (Hangzhou) Co., Ltd. | 2025 | — |
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102520 | BD Nexiva Closed IV Catheter SystemSummary page 6…s: Class II C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is: Predicate Device: K102520- BD Nexiva ™ Closed IV Catheter System D. REASON FOR 510(k) SUBMISSION This Traditional 510(k) for the SURFLO Hybria Closed… | 2011 |
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 21 years and passes through 2 companies; a new generation was cleared every 14.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 6 other devices also cite its predicate K102520.
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?
SURFLO Hybria Closed System Safety IV Catheter is intended to be inserted into a patient’s peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. The device may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. When the device is used with a power injector, the needle-free connector should be removed, and the maximum pressure limit is 325 psi (2.24MPa).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252398: SURFLO Hybria Closed System Safety IV Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252398
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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