510(k) · Cleared

Cleared

Simplicity Starplus Soft Infusion Set

K014061510(k) AbbreviatedCleared Jan 17, 200238-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

Sterling Medivations, Inc. · FPA Set, Administration, Intravascular

Cleared on Jan 17, 2002 as substantially equivalent to K010846 (Sterling Medivations, Inc., 2001) after a 38-day review. Its family tree reaches back 1 generation to 2001.

Decided: Jan 17, 2002
Review: 38 days
Class: Class II
Product code: FPA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K010846 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK010846 Simplicity Silver Set Soft InfusionSterling Medivations, Inc. · 2001
This deviceK014061 Simplicity Starplus Soft Infusion SetSterling Medivations, Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K010846	Simplicity Silver Set Soft Infusion	Sterling Medivations, Inc.	2001	—
0 (this device)	K014061	Simplicity Starplus Soft Infusion Set	Sterling Medivations, Inc.	2002	—

FIG. 1 — Lineage of K014061, 2001–2002Source: 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

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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
*	K010846	Simplicity Silver Set Soft Infusion Summary page 1 …lar catheter. Predicate Device: The predicate device for Sterling’s Simplicity™ StarPlus Soft Infusion set is the Sterling Medivations Simplicity™ Silver Soft Infusion, K010846. Description of the New Device: Sterling Medivations, Inc.’s (“SMI”) Simplicity ™ StarPlus Soft Infusion Set is designed for use…	Sterling Medivations, Inc.	2001	—

Also cleared against K010846: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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 no recall.
1 other device also cites its predicate K010846.

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 intended use of the Simplicity StarPlus Soft Infusion Set is to provide a means for infusion and/or

injection of fluids into the body below the surface of the skin when attached to an external pump or

syringe.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K014061 · printed Nov 4, 2026

Cite this page

510(k) Report. “K014061: Simplicity Starplus Soft Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K014061

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026