510(k) · Cleared
ClearedTerumo Hybria Closed System 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 Apr 15, 2009 as substantially equivalent to K991406 (Terumo Medical Corp., 1999) and 2 other predicates after a 189-day review. Its family tree reaches back 2 generations to 1989. 4 later devices descend from it.
- Decided
- Apr 15, 2009
- Review
- 189 days
- Class
- Class II
- Product code
- FOZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K891087 (1989). 5 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK891087 Terumo Surflo (R) I.V. CatheterTerumo Medical Corp. · 1989 · Recalled
- 1 generation backK991406 Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterTerumo Medical Corp. · 1999
- This deviceK082997 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 · 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 4 of 4 · See all- 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 |
|---|---|---|---|---|---|
| −2 | K891087 | Terumo Surflo (R) I.V. Catheter | Terumo Medical Corp. | 1989 | 1 |
| −1 | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. Catheter | Terumo Medical Corp. | 1999 | — |
| 0 (this device) | 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 | — |
| +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 |
|---|---|---|
| 1993 | 1 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K991406 | Terumo Surflo Flex I.V. Catheter and Terumo Surflash I.V. CatheterSummary page 1…is substantially equivalent with respect to intended use, design, technology/principles of operation, materials and performance to the following: 1. K991406 TERUMO® SURFLASH® INV Catheter 2. K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System 3… | 1999 |
| * | K923702 | Intima Point Guard Intravascular CatheterSummary page 1…, design, technology/principles of operation, materials and performance to the following: 1. K991406 TERUMO® SURFLASH® INV Catheter 2. K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System 3. K032843 Becton Dickinson Nexiva Closed IV Catheter Sys… | 1993 |
| * | K032843 | Nexiva Closed IV Catheter SystemSummary page 1…e following: 1. K991406 TERUMO® SURFLASH® INV Catheter 2. K923702 Becton Dickinson Saf-T-Intima Closed I.V. Catheter System 3. K032843 Becton Dickinson Nexiva Closed IV Catheter System The differences between the devices do not raise any new issues of safet… | 2004 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100282 | Terumo Surshield- Pur Safety I.V. Catheter | 2010 | 3 |
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 20 years and passes through 1 company; a new generation was cleared every 10.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K100282 (Terumo Corp., 2010) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K991406.
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. 2009, 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 Hybria Closed System Safety LV. Catheter is inserted into the patient's vascular system for short term use (<30 days) to withdraw blood samples, administer fluid intravenously, or monitor blood pressure by attaching a monitoring line. The needle shield feature and the needleless access port 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K082997 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082997: Terumo Hybria Closed System 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/K082997
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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