# K984561: Subcutaneous Infusion Sets, MSR Model a & B

- Pathway: 510(k) (Traditional)
- Applicant: Msr, Inc.
- Decided: Feb 4, 1999 after 43 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 K972135 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972135: Maersk Medical Pureline Comfort Subcutaneous Infusion Set, P/L Biomedical (1997) Summary page 1.

## Indications for use
Model A & B Subcutaneous Infusion Set is intended to be used to administer insulin and medications under the skin.

Source page: https://510kreport.com/device/K984561
Methodology: https://510kreport.com/methodology