510(k) · Cleared
ClearedSimplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin
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 21, 2002 as substantially equivalent to K020912 (Sterling Medivations, Inc., 2002) and 1 other predicate after an 11-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- May 21, 2002
- Review
- 11 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972135 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK972135 Maersk Medical Pureline Comfort Subcutaneous Infusion SetP/L Biomedical · 1997 · Recalled
- 2 generations backK014062 Simplicity Easy Access Infusion SetSterling Medivations, Inc. · 2002
- 1 generation backK020912 Simplicity Easy Soft Infusion SetSterling Medivations, Inc. · 2002
- This deviceK021530 Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of…Sterling Medivations, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972135 | Maersk Medical Pureline Comfort Subcutaneous Infusion Set | P/L Biomedical | 1997 | 16 |
| −2 | K014062 | Simplicity Easy Access Infusion Set | Sterling Medivations, Inc. | 2002 | — |
| −1 | K020912 | Simplicity Easy Soft Infusion Set | Sterling Medivations, Inc. | 2002 | — |
| 0 (this device) | K021530 | Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids… | Sterling Medivations, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K020912 | Simplicity Easy Soft Infusion SetSummary page 1…of Device: Intravascular administration set. Classification Name: Percutaneous intravascular catheter, Predicate Device: Simplicity Easy Soft Infusion Set, FDA 510 (k) K020912. Description of the New Device: Sterling Medivations Inc.’s (“SMI") Simplicity Easy P Soft designed for use by people with diabe… | 2002 |
| * | K011187 | Simplicity Soft YP Infusion Set for Use with the Minimed Paragigm Infusion PumpsSummary page 1…the catheter is attached to the infusion device. It is substantially equivalent to the Simplicity ™ Easy Soft Infusion Set, K020912 and Soft YP Infusion Set, FDA 510 (k) K011187. The Simplicity Easy P Soft Infusion Set proposed for commercial distribution is similar in all significant respects to the exis… | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3 months on median.
- 1 of the 4 ancestors has a recall of any class.
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 Easy P 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 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/K021530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021530: Simplicity Easy P Soft Infusion Set for Infusion and/or Injection of Fluids Into the Body Below the Surface of the Skin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021530
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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