# K961474: Polyfin Infusion Set MMT-106/MMT-107/MMT-133

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: May 6, 1996 after 18 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831445 (1983). 2 ancestors in all.
20 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831445: Infusion Sets #'S 124 & 142 Personal, Pacesetter Systems (1983). 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”.
- K861436: Sof Set, Models 111 and 112, Pacesetter Systems (1986) Summary page 1.

## Most influential descendants
- K020530: Evans Sub-Q, Model MC4206 (2002), 17 descendants of its own
- K140131: Sub-Q Subcutaneous Tissue Infusion Set (2014), 8 descendants of its own
- K142319: SCIg60 Infuser, Infuset (2015), 6 descendants of its own
- K082818: Subcutaneous Needle Infusion Set (2008), 6 descendants of its own
- K161906: SCIg60 Infuser (2016), 5 descendants of its own

## Indications for use
The intended use of the new device is subcutaneous infusion of medicine, including insulin, from an external pump, for up to 48 hours.

Source page: https://510kreport.com/device/K961474
Methodology: https://510kreport.com/methodology