510(k) · Cleared
ClearedEvans Sub-Q, Model MC4206
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Evans Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Apr 29, 2002 as substantially equivalent to K961474 (Medtronic Minimed, 1996) after a 69-day review. Its family tree reaches back 2 generations to 1983. 17 later devices descend from it.
- Decided
- Apr 29, 2002
- Review
- 69 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K831445 (1983). 3 ancestors in all. 17 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 1 generation backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- This deviceK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- Descendant · cites it directly · 8 of its ownK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- Descendant · 2 generations on · 6 of its ownK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- Descendant · cites it directly · 6 of its ownK082818 Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008
- Descendant · 3 generations on · 5 of its ownK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
- Descendant · 4 generations on · 3 of its ownK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K140131Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014 · cites it directly8descendants
- K142319SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015 · 2 generations on6descendants
- K082818Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008 · cites it directly6descendants
- K161906SCIg60 InfuserEmed Technologies Corporation · 2016 · 3 generations on5descendants
- K222087SCIg60 Infusion SystemEmed Technologies Corporation · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −1 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| 0 (this device) | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| +1 | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| +2 | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| +1 | K082818 | Subcutaneous Needle Infusion Set | Marcal Medical, Inc. | 2008 | — |
| +3 | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
| +4 | K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 | Decided |
|---|---|---|---|
| * | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133Summary page 1…mon/Usual Name: 1.V. Administration Set . Equivalent legally marketed device: This device is similar in design and in function to the Minimed MMT-106. MMT-107, MMT-133, K961474. . Indications for Use (intended use): “Evans Sub-Q” (Catalog # MC4206) Winged Subcutaneous Infusion Set is intended to provide… | 1996 |
What descends from it? (17)
See all 176 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140131 | Sub-Q Subcutaneous Tissue Infusion Set | 2014 | 8 |
| K082818 | Subcutaneous Needle Infusion Set | 2008 | 6 |
| K102512 | RMS Subcutaneous Needle Set | 2011 | 3 |
| K122404 | Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614… | 2013 | 0 |
| K121092 | Flowease [Subcutaneous] Infusion Set | 2012 | 0 |
| K042666 | Luth-All Sub-Q Needle Set | 2004 | 0 |
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 19 years and passes through 3 companies; a new generation was cleared every 12.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K140131 (Emed Technologies Corporation, 2014) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K961474.
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?
“Evans Sub-Q” (Catalog # MC4206) Winged Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion 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/K020530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020530: Evans Sub-Q, Model MC4206.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020530
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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