# K150562: Safe'n'Sound Staked Passive Delivery System - Plajex version

- Pathway: 510(k) (Abbreviated)
- Applicant: Nemera
- Decided: Jun 2, 2015 after 88 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K060743 (2006). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141664: Safe'n'sound Staked Passive Delivery System - Cone Version, Rexam Healthcare (2014) Summary page 4.

## Indications for use
Single use devices that are indicated for use as an accessory with prefilled ISO Standard plastic syringes to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needle sticks. The intended patient population is unrestricted and may include children and adults, for parenteral methods of administration.

Source page: https://510kreport.com/device/K150562
Methodology: https://510kreport.com/methodology