# K101233: Safe'n'sound Passive Delivery System

- Pathway: 510(k) (Abbreviated)
- Applicant: Rexam Pharma
- Decided: Feb 18, 2011 after 291 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: 1 generation back to K060743 (2006). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 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.

## Most influential descendants
- K141664: Safe'n'sound Staked Passive Delivery System - Cone Version (2014), 1 descendant of its own
- K141464: Novaguard S a Safety System (2014), 1 descendant of its own
- K163511: NovaGuard SA Pro Safety System (2017), 0 descendants of its own
- K150562: Safe'n'Sound Staked Passive Delivery System - Plajex version (2015), 0 descendants of its own
- K112936: Safe'sound Luer Lock Passive Devlivery System (2012), 0 descendants of its own

## Indications for use
Single use devices that are 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 needlesticks. The devices can be used on a wide range of patients including children and adults.

Source page: https://510kreport.com/device/K101233
Methodology: https://510kreport.com/methodology