510(k) · Cleared
ClearedSurshield Safety 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 Sep 17, 2008 as substantially equivalent to K891087 (Terumo Medical Corp., 1989) and 2 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1980. 5 later devices descend from it.
- Decided
- Sep 17, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K801941 (1980). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK801941 Burron Microcath Intra. Cath. PlacementtBurron Medical Products, Inc. · 1980
- 2 generations backK982805 Introcan Safety IV CatheterB.Braun Medical, Inc. · 1999 · Recalled
- 1 generation backK020785 Introcan Safety IV CatheterB.Braun Medical, Inc. · 2002 · Recalled
- This deviceK082362 Surshield Safety I.V. CatheterTerumo Medical Corp. · 2008
- Descendant · cites it directly · 4 of its ownK090973 Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo Corp. · 2009
- Descendant · cites it directly · 3 of its ownK100282 Terumo Surshield- Pur Safety I.V. CatheterTerumo Corp. · 2010
- Descendant · 2 generations on · 1 of its ownK122544 Terumo Surflash Safety I.V. CatheterTerumo Corporation · 2012
- Descendant · 3 generations on · 0 of its ownK141138 Surflash Safety I.V. CatheterKofu Factory of Terumo Corp. · 2014
- Descendant · 2 generations on · 0 of its ownK123267 Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp. · 2012
Most influential descendants
Showing 5 of 5 · See all- K090973Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes)Terumo 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 · 2 generations on1descendant
- K141138Surflash Safety I.V. CatheterKofu Factory of Terumo Corp. · 2014 · 3 generations on0descendants
- K123267Surfflash (R) Plus Safety I.V. CatheterKofu Factory of Terumo Corp. · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K801941 | Burron Microcath Intra. Cath. Placementt | Burron Medical Products, Inc. | 1980 | — |
| −2 | K982805 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 1999 | 1 |
| −1 | K020785 | Introcan Safety IV Catheter | B.Braun Medical, Inc. | 2002 | 2 |
| 0 (this device) | K082362 | Surshield Safety I.V. Catheter | Terumo Medical Corp. | 2008 | — |
| +1 | K090973 | Terumo Surshield Safety I.V. Catheter (18G X 51MM & 20G X 51MM Sizes) | Terumo Corp. | 2009 | — |
| +1 | K100282 | Terumo Surshield- Pur Safety I.V. Catheter | Terumo Corp. | 2010 | — |
| +2 | K122544 | Terumo Surflash Safety I.V. Catheter | Terumo Corporation | 2012 | — |
| +3 | K141138 | Surflash Safety I.V. Catheter | Kofu Factory of Terumo Corp. | 2014 | — |
| +2 | K123267 | Surfflash (R) Plus Safety I.V. Catheter | Kofu Factory of Terumo Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 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? (3)
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 1…Corporation is substantially equivalent to with respect to intended use, design, technology/principles of operation, materials and performance: 1. K891087 TERUMOf® SURFLOz I.V Catheter for the catheter portion only 2. K99 1406 TERUMO~'SURFLASHO I.V Catheter for the need… | 1989 |
| * | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterSummary page 1…technology/principles of operation, materials and performance: 1. K891087 TERUMOf® SURFLOz I.V Catheter for the catheter portion only 2. K99 1406 TERUMO~'SURFLASHO I.V Catheter for the needle portion only 3. K020785 B.BRAUTN Introcan Safety TM I.V. Catheter… | 1999 |
| * | K020785 | Introcan Safety IV CatheterSummary page 1…K891087 TERUMOf® SURFLOz I.V Catheter for the catheter portion only 2. K99 1406 TERUMO~'SURFLASHO I.V Catheter for the needle portion only 3. K020785 B.BRAUTN Introcan Safety TM I.V. Catheter The differences between the devices do not raise any new issues of safety or… | 2002 |
What descends from it? (5)
2 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)
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 28 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K090973 (Terumo Corp., 2009) has gone furthest, with 4 descendants of its own.
- 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. 2008, 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 TERUMO® Surshield® SAFETY I.V. CATHETER is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluids intravenously, or through which to place monitoring equipment such as blood pressure monitors. The needle shield feature aids in the prevention of needle stick injuries. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082362 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082362: Surshield Safety I.V. Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082362
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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