# K122558: Ultrasafe Passive Needle Guard

- Pathway: 510(k) (Special)
- Applicant: Safety Syringes, Inc.
- Decided: Sep 20, 2012 after 29 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). 2 ancestors in all.
4 later devices descend from it; 1 cites 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)
- 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
- K123743: Ultrasafe Plus Passive Needle Guard (2013), 3 descendants of its own
- 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 neediesticks. The intended patient population is unrestricted and may include children and adults, and parenteral methods of administration.

Source page: https://510kreport.com/device/K122558
Methodology: https://510kreport.com/methodology