# K011369: Ultrasafe Passive X-Series, Needle Guard Syringe, Piston (Accessory)

- Pathway: 510(k) (Traditional)
- Applicant: Safety Syringes, Inc.
- Decided: May 29, 2001 after 25 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
No predicates in its family tree.
6 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K122558: Ultrasafe Passive Needle Guard (2012), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K011369
Methodology: https://510kreport.com/methodology