# K223353: DropSafeTM SicuraTM

- Pathway: 510(k) (Traditional)
- Applicant: Pikdare Spa
- Decided: Dec 2, 2022 after 30 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: 7 generations back to K904198 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111797: 27 G X 1/2 K-Pack Surshield Needle, Terumo Europe N.V. (2011) Summary page 5.

## Indications for use
The DropSafeTM SicuraTM are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection

Source page: https://510kreport.com/device/K223353
Methodology: https://510kreport.com/methodology