510(k) · Cleared

Cleared

Victus I.V. Administration Set, Models 27071 and 27072

K030246510(k) TraditionalCleared Feb 26, 200333-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Victus, Inc. · FPA Set, Administration, Intravascular

Cleared on Feb 26, 2003 as substantially equivalent to K921860 (Mcgaw, Inc., 1992) and 4 other predicates after a 33-day review. Its family tree reaches back 1 generation to 1992. 1 of the 7 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.

Decided: Feb 26, 2003
Review: 33 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 6

Its longest line of descent runs back 1 generation to K921860 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly. 1 of the 7 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK921860 Modification to IV SpikeMcgaw, Inc. · 1992 · Recalled
This deviceK030246 Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc. · 2003
Descendant · cites it directly · 0 of its ownK093271 Extension Set (Standardbore Tubing), Extension Set (Minibore…Victus, Inc. · 2010

Class I recalls in this family

K964435 Primary IV Setdirect predicate · 1997

Most influential descendants

Showing 1 of 1 · See all

K093271Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…Victus, Inc. · 2010 · cites it directly0descendants

View 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)	K030246	Victus I.V. Administration Set, Models 27071 and 27072	Victus, Inc.	2003	—
+1	K093271	Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV…	Victus, Inc.	2010	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1995	1	0
1997	2	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0

FIG. 1 — Lineage of K030246, 1992–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K921860	Modification to IV Spike Summary page 1 …istration Set ProCode 80 FPA Predicate Devices BBraudMcGaw IV Administration Sets (Pre-Amendment, and as modified by K92 1860 and K93265), ICU Medical, Inc. standard or custom ClaveB IV systems (K964435), and IC…	Mcgaw, Inc.	1992	6
Kept off the family tree	K093265	BBraudMcGaw IV 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
*	K964435	Primary IV Set Summary page 1 …tration Sets (Pre-Amendment, and as modified by K92 1860 and K93265), ICU Medical, Inc. standard or custom ClaveB IV systems (K964435), and ICU Medical, Inc. ClaveB Connector (K915571; K941190; and K970855). Modifications There are…	Icu Medical, Inc.	1997	Class I
*	K915571	Clave Connector Summary page 1 …2 1860 and K93265), ICU Medical, Inc. standard or custom ClaveB IV systems (K964435), and ICU Medical, Inc. ClaveB Connector (K915571; K941190; and K970855). Modifications There are no modifications to the device design that affect safety and…	Icu Medical, Inc.	1992	3
*	K941190	Clave Needle-Less Connector Open Extension Set Summary page 1 …d K93265), ICU Medical, Inc. standard or custom ClaveB IV systems (K964435), and ICU Medical, Inc. ClaveB Connector (K915571; K941190; and K970855). Modifications There are no modifications to the device design that affect safety and…	Icu Medical, Inc.	1995	1
*	K970855	Clave Connector Summary page 1 …ICU Medical, Inc. standard or custom ClaveB IV systems (K964435), and ICU Medical, Inc. ClaveB Connector (K915571; K941190; and K970855). Modifications There are no modifications to the device design that affect safety and effectivene…	Icu Medical, Inc.	1997	52

Also cleared against K921860: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K093271	Extension Set (Standardbore Tubing), Extension Set (Minibore Tubing), IV Administration…	Victus, Inc.	2010	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K964435Primary IV SetIcu Medical, Inc. · 1997 · Direct predicate · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls

What does this lineage say?

5 of the 5 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K093271 (Victus, Inc., 2010) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K921860.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007high 47,210 (2024) · low 1,499 (2007)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 fluiddmedication to the patient's vascular system through a needle-free system that aids in the elimination of needle-stick injury.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030246 · printed Nov 3, 2026

Cite this page

510(k) Report. “K030246: Victus I.V. Administration Set, Models 27071 and 27072.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K030246

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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