# K972878: Ultrasafe Injection System Needle Guard, Models B50,B100L,B150,B225, and B300

- Pathway: 510(k) (Traditional)
- Applicant: Safety Syringes, Inc.
- Decided: Oct 30, 1997 after 87 days
- Product code: FMF (Syringe, Piston)
- 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 K944425 (1995). 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)
- K944425: Ultrasafe Aspirating Syringe, Safety Syringes, Inc. (1995) Summary page 1.

## Indications for use
Each UltraSafe® Injection System Needle Guard is attached to an ISO standard glass syringe that is pre-filled and equipped with a shield that covers the needle during disposal intending to reduce the occurrence of accidental needle sticks to users. This device is used for a wide range of patients from children to adults and parenteral methods of administration.

Source page: https://510kreport.com/device/K972878
Methodology: https://510kreport.com/methodology