# K082818: Subcutaneous Needle Infusion Set

- Pathway: 510(k) (Traditional)
- Applicant: Marcal Medical, Inc.
- Decided: Dec 23, 2008 after 89 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: 3 generations back to K831445 (1983). 5 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020530: Evans Sub-Q, Model MC4206, Evans Medical, Inc. (2002) Summary page 1.
- K891072: Intravascular Administration Set, Multi-Med, Inc. (1989) Summary page 1.

## Most influential descendants
- K102512: RMS Subcutaneous Needle Set (2011), 3 descendants of its own
- K202279: Insignis Subcutaneous Needle Sets (2021), 0 descendants of its own
- K122404: Model Number: RMS1-2604, RMS1-2614, RMS1-2404, RMS1-2414, RMS2-2604, RMS2-2614, RMS2-2404, RMS2-2414, RMS3-2604, RMS3-26 (2013), 0 descendants of its own
- K120195: Safety Subcutaneous Tissue Infusion Set (2012), 0 descendants of its own
- K121092: Flowease [Subcutaneous] Infusion Set (2012), 0 descendants of its own

## Indications for use
The Subcutaneous Infusion Set is designed specifically for the delivery of medication to the subcutaneous tissue

Source page: https://510kreport.com/device/K082818
Methodology: https://510kreport.com/methodology