510(k) · Cleared
Recalled · Class II · 2015Terumo Surflo (R) 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 23, 1989 after a 114-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it. It has been recalled once.
- Decided
- Jun 23, 1989
- Review
- 114 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- 1
- Predicates
- 0
11 later devices descend from it, 3 citing it directly.
- This deviceK891087 Terumo Surflo (R) I.V. CatheterTerumo Medical Corp. · 1989
- Descendant · cites it directly · 9 of its ownK991406 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 · 2 generations on · 4 of its ownK082997 Terumo Hybria Closed System Safety I.V. CatheterTerumo Medical Corp. · 2009
- Descendant · 2 generations on · 3 of its ownK100282 Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K991406Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterTerumo Medical Corp. · 1999 · cites it directly9descendants
- 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 · 2 generations on4descendants
- K100282Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891087 | Terumo Surflo (R) I.V. Catheter | Terumo Medical Corp. | 1989 | — |
| +1 | 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 | — |
| +2 | K082997 | Terumo Hybria Closed System Safety I.V. Catheter | Terumo Medical Corp. | 2009 | — |
| +2 | K100282 | Terumo Surshield- Pur Safety I.V. Catheter | Terumo Corp. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 5, 2015 | Class II | Z-1896-2017 | Process control | According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into patients. A small percentage of the catheters in the affected… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K991406 (Terumo Medical Corp., 1999) has gone furthest, with 9 descendants of its own.
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 | — |
https://510kreport.com/device/K891087 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891087: Terumo Surflo (R) 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/K891087
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026