510(k) · Cleared
ClearedSimplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion Pumps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterling Medivations, Inc. · FPA Set, Administration, Intravascular
Cleared on May 3, 2002 as substantially equivalent to K020629 (Sterling Medivations, Inc., 2002) and 1 other predicate after a 16-day review. Its family tree reaches back 1 generation to 2001.
- Decided
- May 3, 2002
- Review
- 16 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K011187 (2001). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK011187 Simplicity Soft YP Infusion Set for Use with the Minimed Paragigm…Sterling Medivations, Inc. · 2001
- This deviceK021216 Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm…Sterling Medivations, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K011187 | Simplicity Soft YP Infusion Set for Use with the Minimed Paragigm Infusion Pumps | Sterling Medivations, Inc. | 2001 | — |
| 0 (this device) | K021216 | Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion… | Sterling Medivations, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K020629 | Simplicity Simplex Soft Infusion SetSummary page 1…Classification Name: Percutaneous intravascular catheter. Predjcate Device: Sterling Medivations Sterling Medivations Simplicity Simplex Soft Infusion Set, FDA 510 (k) K 020629 and Sterling Mcdivations Simplicity Soft YP {nfusicn Set KO011187. Description of the New Device: Sterling Medivations Inc.'s (“… | 2002 |
| * | K011187 | Simplicity Soft YP Infusion Set for Use with the Minimed Paragigm Infusion PumpsSummary page 2…e MiniMed Paradigm infirsion pump or syringc. The Simplicity Simplex Infusion Set is substantially equivalent to the Sterling Medivations Simplicity Soft YP Infusion Set K011187 and Simplicity Simplex Soft Infusion Set, FT'A 510 (k) K 020629. Comparison of the Technological Features of the New Device and… | 2001 |
| † | K010373 | Simplicity Soft Y Infusion Set for Use with the Minimed Infusion Pumps and Minimed… | 2001 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 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 Simplex P 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 a MiniMed Paradigm
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/K021216 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021216: Simplicty Simplex P Infusion Set for Use with the Minimed Paradigm Infusion Pumps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021216
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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