# K991979: Sof-Set Micro QR Infusion Set, Models 320 and 321

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Minimed
- Decided: Sep 3, 1999 after 81 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MiniMed Sof-set Ultimate QR infusion sets, models 315 and 316: named in the summary without a submission number

## Most influential descendants
- K012429: Sureset Infusion Set, Model 8023 (2001), 1 descendant of its own
- K033099: Adr Thinset Infusion Set Model, 23-106, 23-109, 43-106, 43-109 (2003), 0 descendants of its own

## Indications for use
The MiniMed Sof-set Micro QR infusion set is indicated for the subcutaneous infusion of medicine, including insulin, from an external infusion pump.

Source page: https://510kreport.com/device/K991979
Methodology: https://510kreport.com/methodology