# K042712: Tamper Evident Ultrasafe Passive Delivery System

- Pathway: 510(k) (Special)
- Applicant: Safety Syringes, Inc.
- Decided: Oct 15, 2004 after 15 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 K011369 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011369: Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory), Safety Syringes, Inc. (2001) Summary page 1.

## Indications for use
Single Use devices that are indicated for use as an accessory with pre-filled ISO Standard glass syringes to aid in the protection of healthcare professionals from accidental needlesticks. These devices can be used on a wide range of patients, including children and adults, and parenteral methods of administration.

Source page: https://510kreport.com/device/K042712
Methodology: https://510kreport.com/methodology