510(k) · Cleared

Recalled · Class II · 2014

Contact Detach

K041545510(k) SpecialCleared Jun 30, 200421-day reviewClass II21 CFR 880.5440Recalls 3

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 Jun 30, 2004 as substantially equivalent to K011071 (Maersk Medical A/S, 2001) and 1 other predicate after a 21-day review. Its family tree reaches back 1 generation to 1997. 2 of the 5 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it. It has been recalled 3 times.

Decided: Jun 30, 2004
Review: 21 days
Class: Class II
Product code: FPA
Recalls: 3
Predicates: 2

Its longest line of descent runs back 1 generation to K972135 (1997). 2 ancestors in all. 2 later devices descend from it, 1 citing it directly. 2 of the 5 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 deviceK041545 Contact DetachUnomedical A/S · 2004
Descendant · cites it directly · 1 of its ownK160648 MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016 · Recalled
Descendant · 2 generations on · 0 of its ownK162812 Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort…Unomedical A/S · 2017 · Recalled (Class I)

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 2 of 2 · See all

K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 2016 · cites it directly1descendant
K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous…Unomedical A/S · 2017 · 2 generations on0descendants

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)	K041545	Contact Detach	Unomedical A/S	2004	—
+1	K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	Unomedical A/S	2016	4
+2	K162812	Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short…	Unomedical A/S	2017	Class I

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	1

FIG. 1 — Lineage of K041545, 1997–2017Source: 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

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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
*	K011071	Paradigm Quick-Set Infusion Set	Maersk Medical A/S	2001	Class I
*	K972135	Maersk Medical Pureline Comfort Subcutaneous Infusion Set Summary page 1 …and the Comfort Sets~m, the Maersk Medical Paradigm Quick Set Infusion set (K0l 1071) and the Maersk Medical Pureline Comfort Subcutaneous Infusion Set (K9721 35). 8.6 Technological Characteristics This modification does not change the technological characteristics of the curren…	P/L Biomedical	1997	16
*	—	unmodified Contact sets Named without a submission number			—
*	—	Comfort Sets Named without a submission number			—

Also cleared against K011071: 5 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K160648	MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®	Unomedical A/S	2016	1

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 7, 2014	Class II	Z-0356-2017	Device Design	Tubing detachment
Nov 7, 2014	Class II	Z-0360-2017	Device Design	Tubing detachment
Nov 4, 2014	Class II	Z-0524-2015	Process change control	Tubing may detach at the connect/disconnect location on the MiniMed Silhouette and MiniMed Sure-T infusion sets. Detachment causes interrupted insulin delivery and the pump will not alarm to notify your patient. This can lead to…

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 2 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K160648 (Unomedical A/S, 2016) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K011071.

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?

The Contact DetachTM is indicated for the infusion of fluids into the body below the surface of the skin when attached to a fluid reservoir.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041545 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041545: Contact Detach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041545

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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