# K123743: Ultrasafe Plus Passive Needle Guard

- Pathway: 510(k) (Traditional)
- Applicant: Safety Syringes, Inc.
- Decided: Mar 26, 2013 after 110 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 K011369 (2001). 3 ancestors in all.
3 later devices descend from it; 2 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)
- K011369: Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory), Safety Syringes, Inc. (2001) Summary page 2.
- K060743: Modification to: Tamper Evident Ultrasafe Passive Delivery System, Ultrasafe Passive Delivery System (X-Series), Safety Syringes, Inc. (2006) Summary page 1.
- K122558: Ultrasafe Passive Needle Guard, Safety Syringes, Inc. (2012) Summary page 1.

## Most influential descendants
- K141464: Novaguard S a Safety System (2014), 1 descendant of its own
- K230287: SaviSafe Safety Device (2023), 0 descendants of its own
- K163511: NovaGuard SA Pro Safety System (2017), 0 descendants of its own

## 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, patients who self-inject doctor prescribed medications and individuals that assist self-injecting patients, from accidental needlesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration. Additionally, the PLUS device is designed with a larger viewing window indicated where pharma company offering is a low fill volume and instructions request visualization. The PLUS device is designed with a robust plunger and built in extended finger flanges indicated where pharma customer offering is viscous.

Source page: https://510kreport.com/device/K123743
Methodology: https://510kreport.com/methodology