510(k) · Cleared

Cleared

Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion Sets

K070430510(k) TraditionalCleared Apr 4, 200750-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

Unomedical A/S · FPA Set, Administration, Intravascular

Cleared on Apr 4, 2007 as substantially equivalent to K011071 (Maersk Medical A/S, 2001) and 1 other predicate after a 50-day review. Its family tree reaches back 1 generation to 1999. 1 of the 3 devices in its family, counting itself, has a Class I recall.

Decided: Apr 4, 2007
Review: 50 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K991759 (1999). 2 ancestors in all. No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK991759 Maersk Medical Contour Infusion SetMaersk Medical A/S · 1999
This deviceK070430 Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion SetsUnomedical A/S · 2007

Class I recalls in this family

K011071 Paradigm Quick-Set Infusion Setdirect predicate · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K991759	Maersk Medical Contour Infusion Set	Maersk Medical A/S	1999	—
0 (this device)	K070430	Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion Sets	Unomedical A/S	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	1

FIG. 1 — Lineage of K070430, 1999–2007Source: 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? (2)

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
*	K991759	Maersk Medical Contour Infusion Set Summary page 1 …s are substantially equivalent to the current Paradigm Quick-See (KO1 1071) sets. The Quick-Set IIsets are substantially equivalent to the current Quick-See (K991759) sets. 8.6 Classification Class: II Pa…	Maersk Medical A/S	1999	—

Also cleared against K011071: 5 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.

K011071Paradigm Quick-Set Infusion SetMaersk Medical A/S · 2001 · Direct predicate · ◆ in the 2001 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
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. 2007, 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?

These sets are indicated for the subcutaneous infusion of medication, including insulin from compatible infusion pumps.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070430 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070430: Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070430

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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