510(k) · Cleared

Recalled · Class II · 2022

Unomedical Monica Infusion Set

K032854510(k) SpecialCleared Oct 9, 200327-day reviewClass II21 CFR 880.5440Recalls 1

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

Unomedical A/S · FPA Set, Administration, Intravascular

Cleared on Oct 9, 2003 as substantially equivalent to K991759 (Maersk Medical A/S, 1999) and 3 other predicates after a 27-day review. Its family tree reaches back 1 generation to 1997. 2 of the 19 devices in its family, counting itself, have a Class I recall. 14 later devices descend from it. It has been recalled once.

Decided: Oct 9, 2003
Review: 27 days
Class: Class II
Product code: FPA
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K972135 (1997). 4 ancestors in all. 14 later devices descend from it, 8 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 1 generation backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
This deviceK032854 Unomedical Monica Infusion SetUnomedical A/S · 2003
Descendant · cites it directly · 3 of its ownK173879 MiniMed Mio Advance infusion setUnomedical A/S · 2018
Descendant · cites it directly · 2 of its ownK061374 Intuition Infusion SetsUnomedical A/S · 2006
Descendant · 2 generations on · 1 of its ownK243841 Sparta Infusion Set for InsulinDeka Research and Development · 2025
Descendant · 2 generations on · 1 of its ownK242692 SteadiSet Infusion SetCapillary Biomedical, LLC · 2025
Descendant · cites it directly · 1 of its ownK160648 MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016 · Recalled

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2005high 3 (2025) · low 0 (2007)2026

Class I recalls in this family

K011071 Paradigm Quick-Set Infusion Setdirect predicate · 2001
K162812 Unomedical Comfort Subcutaneous Infusion Set…2 generations on · 2017

Most influential descendants

Showing 5 of 14 · See all

K173879MiniMed Mio Advance infusion setUnomedical A/S · 2018 · cites it directly3descendants
K061374Intuition Infusion SetsUnomedical A/S · 2006 · cites it directly2descendants
K243841Sparta Infusion Set for InsulinDeka Research and Development · 2025 · 2 generations on1descendant
K242692SteadiSet Infusion SetCapillary Biomedical, LLC · 2025 · 2 generations on1descendant
K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972135	Maersk Medical Pureline Comfort Subcutaneous Infusion Set	P/L Biomedical	1997	16
0 (this device)	K032854	Unomedical Monica Infusion Set	Unomedical A/S	2003	—
+1	K173879	MiniMed Mio Advance infusion set	Unomedical A/S	2018	—
+1	K061374	Intuition Infusion Sets	Unomedical A/S	2006	—
+2	K243841	Sparta Infusion Set for Insulin	Deka Research and Development	2025	—
+2	K242692	SteadiSet Infusion Set	Capillary Biomedical, LLC	2025	—
+1	K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	Unomedical A/S	2016	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1999	2	0
2001	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	1	0
2012	2	0
2013	1	0
2016	1	0
2017	1	1
2018	1	0
2019	1	0
2021	1	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K032854, 1997–2026Source: 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.

2 devices in this family have 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? (4)

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
*	K991759	Maersk Medical Contour Infusion Set	Maersk Medical A/S	1999	—
*	K011071	Paradigm Quick-Set Infusion Set	Maersk Medical A/S	2001	Class I
*	K972135	Maersk Medical Pureline Comfort Subcutaneous Infusion Set Summary page 1 …K9917.59 Maersk Medical Paradigm Quick Set Infusion set , 5 10K number KO1 1071 Maersk Medical Pureline Comfort Subcutaneous Infusion Set, 5 10K number K972 135 MiniMed Quick-Serter Infusion Set Insertion System, 510K number K992300 Description of the Modified Device: The Unomedi…	P/L Biomedical	1997	16
*	K992300	Quick-Serter, Model 395 Summary page 1 …r KO1 1071 Maersk Medical Pureline Comfort Subcutaneous Infusion Set, 5 10K number K972 135 MiniMed Quick-Serter Infusion Set Insertion System, 510K number K992300 Description of the Modified Device: The Unomedical Monica Set is an infusion administration set, connecting to a reservoirli…	Medtronic Minimed	1999	—

Also cleared against K991759: 2 other devices →

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K173879	MiniMed Mio Advance infusion set	Unomedical A/S	2018	3
K061374	Intuition Infusion Sets	Unomedical A/S	2006	2
K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	Unomedical A/S	2016	1
K120872	Asante Conset and Asante Comfort Subcutaneous Infusion Sets for Use with Asante Pearl…	Unomedical A/S Infusion Devices	2012	1
K051264	Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion Pumps	Unomedical A/S	2005	1
K192647	neria guard Infusion Set	Unomedical A/S	2019	0
K132142	Neria Soft 90 Infusion Set	Unomedical A/S	2013	0
K120337	I-Port Advance Injection Port	Unomedical A/S	2012	0

Has anything in its family been recalled? (2 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 21, 2022	Class II	Z-1810-2022	Labeling Change Control	The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.

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.

K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall
K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 2017 · 2 generations on · ◆ in the 2017 descendants bar of FIG. 13 Class I recalls

What does this lineage say?

2 of the 4 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K173879 (Unomedical A/S, 2018) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K991759.

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?

Unomedical Monica Infusion Sets are indicated for the subcutaneous infusion of medication from an external pump.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032854 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032854: Unomedical Monica Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032854

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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