# K112936: Safe'sound Luer Lock Passive Devlivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: Rexam Consummer Plastics Inc.D/B/A Rexam Pharma
- Decided: Jan 20, 2012 after 109 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060743: Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series), Safety Syringes, Inc. (2006) Summary page 1.
- K101233: Safe'n'sound Passive Delivery System, Rexam Pharma (2011) Summary page 1.

## Indications for use
Single use devices that are indicated for use as an accessory with BD Hypak Sterile Clean Fill (SCF) glass Prefilled Syringes 1 mL long to aid in the protection of healthcare professionals, patients who self-inject doctor prescribed medications, and individuals that assist self-injecting patients, from accidental needlesticks. The devices can be used on a wide range of patients including children and adults.

Source page: https://510kreport.com/device/K112936
Methodology: https://510kreport.com/methodology