# K170988: DropSafe Safety Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Htl-Strefa S.A
- Decided: Dec 12, 2017 after 253 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K202319: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) (2021), 1 descendant of its own
- K230043: Insulin Pen Needle (2023), 0 descendants of its own
- K221176: Insulin Pen Needle (2022), 0 descendants of its own
- K211716: DropSafe Safety Pen Needles (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K170988
Methodology: https://510kreport.com/methodology