510(k) · Cleared
ClearedPolyfin Infusion Set MMT-106/MMT-107/MMT-133
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Minimed · FPA Set, Administration, Intravascular
Cleared on May 6, 1996 as substantially equivalent to K831445 (Pacesetter Systems, 1983) and 1 other predicate after an 18-day review. Its family tree reaches back 1 generation to 1983. 20 later devices descend from it.
- Decided
- May 6, 1996
- Review
- 18 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K831445 (1983). 2 ancestors in all. 20 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK831445 Infusion Sets #'S 124 & 142 PersonalPacesetter Systems · 1983
- This deviceK961474 Polyfin Infusion Set MMT-106/MMT-107/MMT-133Medtronic Minimed · 1996
- Descendant · cites it directly · 17 of its ownK020530 Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002
- Descendant · 2 generations on · 8 of its ownK140131 Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014
- Descendant · 3 generations on · 6 of its ownK142319 SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015
- Descendant · 2 generations on · 6 of its ownK082818 Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008
- Descendant · 4 generations on · 5 of its ownK161906 SCIg60 InfuserEmed Technologies Corporation · 2016
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K020530Evans Sub-Q, Model MC4206Evans Medical, Inc. · 2002 · cites it directly17descendants
- K140131Sub-Q Subcutaneous Tissue Infusion SetEmed Technologies Corporation · 2014 · 2 generations on8descendants
- K142319SCIg60 Infuser, InfusetEmed Technologies Corporation · 2015 · 3 generations on6descendants
- K082818Subcutaneous Needle Infusion SetMarcal Medical, Inc. · 2008 · 2 generations on6descendants
- K161906SCIg60 InfuserEmed Technologies Corporation · 2016 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K831445 | Infusion Sets #'S 124 & 142 Personal | Pacesetter Systems | 1983 | — |
| 0 (this device) | K961474 | Polyfin Infusion Set MMT-106/MMT-107/MMT-133 | Medtronic Minimed | 1996 | — |
| +1 | K020530 | Evans Sub-Q, Model MC4206 | Evans Medical, Inc. | 2002 | — |
| +2 | K140131 | Sub-Q Subcutaneous Tissue Infusion Set | Emed Technologies Corporation | 2014 | — |
| +3 | K142319 | SCIg60 Infuser, Infuset | Emed Technologies Corporation | 2015 | — |
| +2 | K082818 | Subcutaneous Needle Infusion Set | Marcal Medical, Inc. | 2008 | — |
| +4 | K161906 | SCIg60 Infuser | Emed Technologies Corporation | 2016 | — |
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 |
|---|---|---|
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K831445 | Infusion Sets #'S 124 & 142 Personal Our OCR of the scanned summary read K838445, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Pacesetter infusion set, model 124 and 142”. | 1983 |
| * | K861436 | Sof Set, Models 111 and 112Summary page 1…et, Models MMT-106, MMT-107, and MMT-133. C. Predicate device: Pacesetter infusion set, model 124 and 142 (K838445A); Sof-set® Infusion Set, Models MMT-111 and MMT-112 (K861436). D. Description of new device: This infusion set is intended for the administration of medicine, including insulin, from a port… | 1986 |
What descends from it? (20)
See all 203 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K020530 (Evans Medical, Inc., 2002) has gone furthest, with 17 descendants of its own.
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 new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.
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/K961474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961474: Polyfin Infusion Set MMT-106/MMT-107/MMT-133.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K961474
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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