510(k) · Cleared

Cleared

Orbit Infusion Set

K130468510(k) SpecialCleared Mar 19, 201322-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

Ypsomed AG · FPA Set, Administration, Intravascular

Cleared on Mar 19, 2013 as substantially equivalent to K033290 (Icu Medical, Inc., 2004) after a 22-day review. Its family tree reaches back 1 generation to 2004. 5 later devices descend from it.

Decided: Mar 19, 2013
Review: 22 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K033290 (2004). 5 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK033290 Talon Infusion Set, Model IP XXXXIcu Medical, Inc. · 2004 · Recalled
This deviceK130468 Orbit Infusion SetYpsomed AG · 2013
Descendant · cites it directly · 3 of its ownK150059 BD FlowSmart SetBecton, Dickinson Company · 2015
Descendant · 2 generations on · 2 of its ownK153257 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015
Descendant · 3 generations on · 1 of its ownK160651 BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2016 · Recalled
Descendant · 4 generations on · 0 of its ownK181718 BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company · 2018
Descendant · cites it directly · 0 of its ownK150921 Orbit Infusion SetYpsomed AG · 2016

Most influential descendants

Showing 5 of 5 · See all

K150059BD FlowSmart SetBecton, Dickinson Company · 2015 · cites it directly3descendants
K153257BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2015 · 2 generations on2descendants
K160651BD FlowSmart Set, MiniMed Pro-SetBecton, Dickinson and Company · 2016 · 3 generations on1descendant
K181718BD FlowSmart Set/MiniMed Pro-SetBecton, Dickinson and Company · 2018 · 4 generations on0descendants
K150921Orbit Infusion SetYpsomed AG · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K033290	Talon Infusion Set, Model IP XXXX	Icu Medical, Inc.	2004	3
0 (this device)	K130468	Orbit Infusion Set	Ypsomed AG	2013	—
+1	K150059	BD FlowSmart Set	Becton, Dickinson Company	2015	—
+2	K153257	BD FlowSmart Set, MiniMed Pro-Set	Becton, Dickinson and Company	2015	—
+3	K160651	BD FlowSmart Set, MiniMed Pro-Set	Becton, Dickinson and Company	2016	2
+4	K181718	BD FlowSmart Set/MiniMed Pro-Set	Becton, Dickinson and Company	2018	—
+1	K150921	Orbit Infusion Set	Ypsomed AG	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2015	2	0
2016	2	0
2018	1	0

FIG. 1 — Lineage of K130468, 2004–2018Source: 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.

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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K033290	Talon Infusion Set, Model IP XXXX Summary page 1 …omed acquired the Orbit infusion set business of ICU Medical Inc., USA in November 2011, including 510(k) K033290 under which the devices were cleared for marketing as the Talon Infusion Set.…	Icu Medical, Inc.	2004	3

What descends from it? (5)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K150059	BD FlowSmart Set	Becton, Dickinson Company	2015	3
K150921	Orbit Infusion Set	Ypsomed AG	2016	0

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?

Its one ancestor has a recall.
Of its descendants, K150059 (Becton, Dickinson Company, 2015) has gone furthest, with 3 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

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?

Orbit Infusion Sets ate intended for the subcutaneous delivery of fluids and medication, such as insulin, from an external infusion pump.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K130468 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130468: Orbit Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130468

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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