510(k) · Cleared
ClearedFlu Ven TR-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venospital, Inc. · KSB Set, Transfer (Blood/Plasma)
Cleared on Sep 4, 1979 after a 78-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 4, 1979
- Review
- 78 days
- Class
- Class II
- Product code
- KSB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 1 citing it directly.
- This deviceK791131 Flu Ven TR-1Venospital, Inc. · 1979
- Descendant · cites it directly · 7 of its ownK041178 Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004
- Descendant · 2 generations on · 5 of its ownK133147 Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014
- Descendant · 3 generations on · 2 of its ownK173913 MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018
- Descendant · 4 generations on · 1 of its ownK200280 MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020
- Descendant · 3 generations on · 1 of its ownK161723 ulrich Transfer SetUlrich GmbH & Co. KG · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K041178Empower Transfer Set, (Cat. NO. 7725)E-Z-Em, Inc. · 2004 · cites it directly7descendants
- K133147Bracco Injeenering Transfer SetBracco Injeneering S.A. · 2014 · 2 generations on5descendants
- K173913MEDRAD® Imaging Bulk Package Transfer SetBayer U.S., LLC · 2018 · 3 generations on2descendants
- K200280MEDRAD Imaging Bulk Package Transfer SpikeBayer Medical Care, Inc. · 2020 · 4 generations on1descendant
- K161723ulrich Transfer SetUlrich GmbH & Co. KG · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K791131 | Flu Ven TR-1 | Venospital, Inc. | 1979 | — |
| +1 | K041178 | Empower Transfer Set, (Cat. NO. 7725) | E-Z-Em, Inc. | 2004 | — |
| +2 | K133147 | Bracco Injeenering Transfer Set | Bracco Injeneering S.A. | 2014 | — |
| +3 | K173913 | MEDRAD® Imaging Bulk Package Transfer Set | Bayer U.S., LLC | 2018 | — |
| +4 | K200280 | MEDRAD Imaging Bulk Package Transfer Spike | Bayer Medical Care, Inc. | 2020 | — |
| +3 | K161723 | ulrich Transfer Set | Ulrich GmbH & Co. KG | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2026 | 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 KSB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041178 | Empower Transfer Set, (Cat. NO. 7725) | 2004 | 7 |
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?
- Of its descendants, K041178 (E-Z-Em, Inc., 2004) has gone furthest, with 7 descendants of its own.
How does its category compare?
All KSB devicesKSB Set, Transfer (Blood/Plasma): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KSB
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · KSB
Too few KSB 510(k)s in any year since 2007 to give a median.
Recalls per year · KSB
No recall names KSB since 2007.
Adverse event reports per year · KSB
11in 2019
MAUDE reports naming product code KSB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 1 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K791131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K791131: Flu Ven TR-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K791131
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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