510(k) · Cleared

Cleared

Volumat Polyethylene I.V. Administration Set

K221121510(k) TraditionalCleared Jun 16, 2023424-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

Fresenius Kabi · FPA Set, Administration, Intravascular

Cleared on Jun 16, 2023 as substantially equivalent to K203609 (Baxter Healthcare Corporation, 2021) after a 424-day review. Its family tree reaches back 3 generations to 2000. 1 of the 4 devices in its family, counting itself, has a Class I recall.

Decided: Jun 16, 2023
Review: 424 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K003225 (2000). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 3 generations backK003225 Solution Administration Sets with Capless Luer Activated ValveBaxter Healthcare Corp · 2000 · Recalled
2 generations backK112893 Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter…Baxter Healthcare Corporation · 2011 · Recalled (Class I)
1 generation backK203609 Intravascular Administration SetsBaxter Healthcare Corporation · 2021 · Recalled
This deviceK221121 Volumat Polyethylene I.V. Administration SetFresenius Kabi · 2023

Class I recalls in this family

K112893 Clearlink Luer Activated Valve, Clearlink System…2 generations back · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K003225	Solution Administration Sets with Capless Luer Activated Valve	Baxter Healthcare Corp	2000	18
−2	K112893	Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension…	Baxter Healthcare Corporation	2011	Class I
−1	K203609	Intravascular Administration Sets	Baxter Healthcare Corporation	2021	5
0 (this device)	K221121	Volumat Polyethylene I.V. Administration Set	Fresenius Kabi	2023	—

FIG. 1 — Lineage of K221121, 2000–2023Source: 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

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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
*	K203609	Intravascular Administration Sets Summary page 5 …stration Set Classification Name: 21 CFR 880.5440 Regulatory Class: Class II Product Code: FPA 510(k) Number: K203609 5. Device Description The Volumat Polyethylene I.V. Administration Sets (PE Sets) are available for dedicated use with the Agil…	Baxter Healthcare Corporation	2021	5

Also cleared against K203609: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.

K112893Clearlink Luer Activated Valve, Clearlink System Non-Dehp Catheter Extension SetsBaxter Healthcare Corporation · 2011 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 23 years and passes through 3 companies; a new generation was cleared every 10.0 years on median.
3 of the 3 ancestors have a recall of any class; 1 has a Class I recall.
3 other devices also cite its predicate K203609.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?

I.V. Administration Set for the infusion of parenteral fluids and medications from a container into the patient’s vascular system through a vascular access device with Agilia VP MC/Volumat MC Agilia pump or gravity only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K221121 · printed Nov 5, 2026

Cite this page

510(k) Report. “K221121: Volumat Polyethylene I.V. Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221121

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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