# K191853: Dual-Safety Pen Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Sep 5, 2019 after 57 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 K973899 (1997). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle, Promisemed Hangzhou Meditech Co., Ltd. (2017) Summary page 4.

## Most influential descendants
- K202682: Promisemed Triple Safety Pen Needle (2020), 0 descendants of its own

## Indications for use
The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

Source page: https://510kreport.com/device/K191853
Methodology: https://510kreport.com/methodology