# K202682: Promisemed Triple Safety Pen Needle

- Pathway: 510(k) (Special)
- Applicant: Promisemed Hangzhou Meditech Co., Ltd.
- Decided: Nov 24, 2020 after 70 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: 8 generations back to K973899 (1997). 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)
- K191853: Dual-Safety Pen Needle, Promisemed Hangzhou Meditech Co., Ltd. (2019) Summary page 4.

## Indications for use
Promisemed Triple Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin.

Source page: https://510kreport.com/device/K202682
Methodology: https://510kreport.com/methodology