# K203792: Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle

- Pathway: 510(k) (Abbreviated)
- Applicant: Pikdare Spa
- Decided: Jan 20, 2023 after 753 days
- Product code: FMI (Needle, Hypodermic, Single Lumen)
- Device class: 2
- Regulation: 21 CFR 880.5570
- 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 K051899 (2005). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192082: Droplet Pen Needle 34G, Htl-Strefa S.A (2020) Summary page 5.

## Indications for use
Sterile, single use needles intended for use with pen injector devices for the subcutaneous injection of drugs

Source page: https://510kreport.com/device/K203792
Methodology: https://510kreport.com/methodology