# K141664: Safe'n'sound Staked Passive Delivery System - Cone Version

- Pathway: 510(k) (Abbreviated)
- Applicant: Rexam Healthcare
- Decided: Oct 2, 2014 after 101 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: 2 generations back to K060743 (2006). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101233: Safe'n'sound Passive Delivery System, Rexam Pharma (2011) Summary page 4.

## Most influential descendants
- K150562: Safe'n'Sound Staked Passive Delivery System - Plajex version (2015), 0 descendants of its own

## Indications for use
Single use device that is indicated for use as an accessory with sterile 1 mL-long staked needle prefilled ISO Standard glass 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 devices can be used on a wide range of patients including children and adults.

Source page: https://510kreport.com/device/K141664
Methodology: https://510kreport.com/methodology