# K202279: Insignis Subcutaneous Needle Sets

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Health Sciences, LLC
- Decided: Aug 13, 2021 after 367 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: 5 generations back to K831445 (1983). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102512: RMS Subcutaneous Needle Set, Repro-Med Systems, Inc. (2011) Summary page 4.

## Indications for use
Insignis® Subcutaneous Needle Sets are intended for the delivery of medication to the subcutaneous tissue for use not to exceed 24 hours.

Source page: https://510kreport.com/device/K202279
Methodology: https://510kreport.com/methodology