510(k) · Cleared
ClearedTerumo Surflo I.V. Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo (Philippines) Corporation · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jun 12, 2014 as substantially equivalent to K891087 (Terumo Medical Corp., 1989) after a 230-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Jun 12, 2014
- Review
- 230 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K891087 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK891087 Terumo Surflo (R) I.V. CatheterTerumo Medical Corp. · 1989 · Recalled
- This deviceK133280 Terumo Surflo I.V. CatheterTerumo (Philippines) Corporation · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K891087 | Terumo Surflo (R) I.V. Catheter | Terumo Medical Corp. | 1989 | 1 |
| 0 (this device) | K133280 | Terumo Surflo I.V. Catheter | Terumo (Philippines) Corporation | 2014 | — |
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 |
|---|---|---|---|
| * | K891087 | Terumo Surflo (R) I.V. CatheterSummary page 2…avascular catheter C. PREDICATE DEVICE (807.92(a)(3)) The legally marketed device to which substantial equivalence is claimed is the TERUMO® SURFLO© IX. Catheter (K89 1087), manufactured by Terumo Medical Corporation, Elkton, Maryland. D. REASON FOR 510(K) SUBMISSION This premarket notificatio… | 1989 |
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?
- Its one ancestor has a recall.
- 2 other devices also cite its predicate K891087.
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. 2014, 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?
TERUMO®D SURFL0OD I.V. Catheter is inserted into the patient's vascular system for short term use (less than 30 days) to withdraw blood samples, monitor blood pressure, or administer fluids intravenously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133280 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133280: Terumo Surflo I.V. Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133280
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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