# K172095: Autokeeper

- Pathway: 510(k) (Traditional)
- Applicant: Medexel Co.,Ltd
- Decided: Jul 24, 2018 after 378 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K210748: Well-life TM Pen Needles, Well-life TM Safety Pen Needles (2022), 1 descendant of its own
- K260855: Profoject™ Safety Pen Needles (2026), 0 descendants of its own

## Indications for use
Autokeeper® Safety Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. Additionally, the attached safety shield automatically locks in place and reduces the occurrence of accidental needle sticks from the patient end of the needle. The shield also serves to hide the needle before and after injection.

Source page: https://510kreport.com/device/K172095
Methodology: https://510kreport.com/methodology