510(k) · Cleared
ClearedSub-Q Subcutaneous Tissue Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Emed Technologies Corporation · FPA Set, Administration, Intravascular
Cleared on Apr 3, 2014 as substantially equivalent to K020530 (Evans Medical, Inc., 2002) after a 76-day review. Its family tree reaches back 3 generations to 1983. 8 later devices descend from it.
- Decided
- Apr 3, 2014
- Review
- 76 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831445 (1983). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- 2 generations backK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- 1 generation backK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- This deviceK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- Descendant · cites it directly · 6 of its ownK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- Descendant · 2 generations on · 5 of its ownK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
- Descendant · 3 generations on · 3 of its ownK222087 SCIg60 Infusion SystemEmed Technologies Corporation · 2022
- Descendant · 4 generations on · 1 of its ownK240148 SCIg60 Infusion SystemEmed Technologies Corporation · 2024
- Descendant · 5 generations on · 0 of its ownK251105 Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K142319SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015 · cites it directly6descendants
- K161906SCIg60 InfuserEmed Technologies Corporation · 2016 · 2 generations on5descendants
- K222087SCIg60 Infusion SystemEmed Technologies Corporation · 2022 · 3 generations on3descendants
- K240148SCIg60 Infusion SystemEmed Technologies Corporation · 2024 · 4 generations on1descendant
- K251105Tetra (TM-20); Tetra (TM-50)Emed Technologies Corporation · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| −2 | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| −1 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| 0 (this device) | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| +1 | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| +2 | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
| +3 | K222087 | SCIg60 Infusion System | Emed Technologies Corporation | 2022 | — |
| +4 | K240148 | SCIg60 Infusion System | Emed Technologies Corporation | 2024 | — |
| +5 | K251105 | Tetra (TM-20); Tetra (TM-50) | Emed Technologies Corporation | 2025 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 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 |
|---|---|---|---|
| * | K020530 | Evans Sub-Q, Model MC4206Summary page 1…Product Code and Class EPA, Class 11 Predicate Device Evans SUR-Q Subcutaneous Tissue Infusion Set (K020530) Submitter Peter Kollings EMED Technologies Corporation… | 2002 |
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 31 years and passes through 4 companies; a new generation was cleared every 11.9 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K142319 (Emed Technologies Corporation, 2015) has gone furthest, with 6 descendants of its own.
- 5 other devices also cite its predicate K020530.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
SUB-Q Subcutaneous Tissue Infusion Set is intended to provide subcutaneous infusion of medicine from an external infusion pump or syringe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140131: Sub-Q Subcutaneous Tissue Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140131
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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