510(k) · Cleared
ClearedVictus I.V. Administration Set, Models 27058, 27059,27062
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Victus, Inc. · FPA Set, Administration, Intravascular
Cleared on Dec 10, 2002 as substantially equivalent to K921860 (Mcgaw, Inc., 1992) after a 55-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it.
- Decided
- Dec 10, 2002
- Review
- 55 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K921860 (1992). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK921860 Modification to IV SpikeMcgaw, Inc. · 1992 · Recalled
- This deviceK023469 Victus I.V. Administration Set, Models 27058, 27059,27062Victus, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK093271 Extension Set (Standardbore Tubing), Extension Set (Minibore…Victus, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK041495 Pentadeflue IV Solution Administration SetsPentaferte S.P.A · 2005
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921860 | Modification to IV Spike | Mcgaw, Inc. | 1992 | 6 |
| 0 (this device) | K023469 | Victus I.V. Administration Set, Models 27058, 27059,27062 | Victus, Inc. | 2002 | — |
| +1 | K093271 | Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV… | Victus, Inc. | 2010 | — |
| +1 | K041495 | Pentadeflue IV Solution Administration Sets | Pentaferte S.P.A | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K921860 | Modification to IV SpikeSummary page 1…80.5440 Intra Vascular Administration Set Predicate Devices BBraun-McGaw N Administration Sets ere-Amendment, and as modified by K92 1860 and K93265) Modifications There are no modifications to the device design that affect safety & eff… | 1992 |
| Kept off the family tree | K093265 | BBraun-McGaw N Administration Sets Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree | |
| * | — | BBraun-McGaw N Administration Sets (pre-Amendment) Named without a submission number |
What descends from it? (2)
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?
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
To administer IV fluid/medication to the patient’s vascular system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023469 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023469: Victus I.V. Administration Set, Models 27058, 27059,27062.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023469
Report an extraction error
Are you the manufacturer?
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