510(k) · Cleared
ClearedTerumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terumo Medical Corp. · FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cleared on Jun 16, 1999 as substantially equivalent to K971339 (Becton Dickinson Vascular Access, Inc., 1997) and 1 other predicate after a 55-day review. Its family tree reaches back 1 generation to 1989. 9 later devices descend from it.
- Decided
- Jun 16, 1999
- Review
- 55 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K891087 (1989). 2 ancestors in all. 9 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK891087 Terumo Surflo (R) I.V. CatheterTerumo Medical Corp. · 1989 · Recalled
- This deviceK991406 Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterTerumo Medical Corp. · 1999
- Descendant · cites it directly · 5 of its ownK082362 Surshield Safety I.V. CatheterTerumo Medical Corp. · 2008
- Descendant · 2 generations on · 4 of its ownK090973 Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp. · 2009
- Descendant · cites it directly · 4 of its ownK082997 Terumo Hybria Closed System Safety I.V. CatheterTerumo Medical Corp. · 2009
- Descendant · cites it directly · 3 of its ownK100282 Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010
- Descendant · cites it directly · 1 of its ownK122544 Terumo Surflash Safety I.V. CatheterTerumo Corporation · 2012
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082362Surshield Safety I.V. CatheterTerumo Medical Corp. · 2008 · cites it directly5descendants
- K090973Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp. · 2009 · 2 generations on4descendants
- K082997Terumo Hybria Closed System Safety I.V. CatheterTerumo Medical Corp. · 2009 · cites it directly4descendants
- K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010 · cites it directly3descendants
- K122544Terumo Surflash Safety I.V. CatheterTerumo Corporation · 2012 · cites it directly1descendant
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) | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter | Terumo Medical Corp. | 1999 | — |
| +1 | K082362 | Surshield Safety I.V. Catheter | Terumo Medical Corp. | 2008 | — |
| +2 | K090973 | Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes) | Terumo Corp. | 2009 | — |
| +1 | K082997 | Terumo Hybria Closed System Safety I.V. Catheter | Terumo Medical Corp. | 2009 | — |
| +1 | K100282 | Terumo Surshield- Pur Safety I.V. Catheter | Terumo Corp. | 2010 | — |
| +1 | K122544 | Terumo Surflash Safety I.V. Catheter | Terumo Corporation | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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.
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? (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 |
|---|---|---|---|
| * | K971339 | Insyte, Insyte-W, Insyte Autoguard CathetersSummary page 3…iples of operation, materials and performance to the cleared Becton Dickinson (B-D®) Insyte® L.V. Catheter and the B-D Insyte (N) I.V. Catheter, which are the subject of K971339 (unable to confirm); and to the Terumo® Surflo® 1.V. Catheter which is the subject of K891087. PRINCIPLE OF OPERATION/TECHNOLOGY… | 1997 |
| * | K891087 | Terumo Surflo (R) I.V. CatheterSummary page 2…Page 2 === SECTION II: Summary of Safety and Effectiveness The needle assembly has the same specifications as the Terumo® Surflo® I.V. Catheter, which is the subject of K891087. The transparent needle hubs permit flashback detection when the cannula enters the vessel. The filter cap with an air filter is… | 1989 |
What descends from it? (9)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082362 | Surshield Safety I.V. Catheter | 2008 | 5 |
| K082997 | Terumo Hybria Closed System Safety I.V. Catheter | 2009 | 4 |
| K100282 | Terumo Surshield- Pur Safety I.V. Catheter | 2010 | 3 |
| K122544 | Terumo Surflash Safety I.V. Catheter | 2012 | 1 |
| K083429 | I.V. Catheter, Models: Type I, Type Y, Type Straight | 2009 | 1 |
| K123267 | Surfflash (R) Plus Safety I.V. Catheter | 2012 | 0 |
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?
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.
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 TERUMO® SURFLO® FLEX L.V. Catheters and the TERUMO® SURFLASH™ 1.V. Catheters are devices consisting of a slender, flexible, radio-opaque, plastic catheter with a hub. The plastic catheter is inserted into the patient’s vascular system for short term use to withdraw samples, administer fluid intravenously or through which to place monitoring equipment such as blood pressure monitors. The stainless steel cannula, placed in the catheter to maintain rigidity, is withdrawn after the catheter is placed in the vascular system.
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/K991406 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991406: Terumo Surflo Flex I.V. Catheter and Terumo Surflash 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/K991406
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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