# K972877: Ultrasafe Injection System Model C200 Injector with Needle Guard

- Pathway: 510(k) (Traditional)
- Applicant: Safety Syringes, Inc.
- Decided: Feb 26, 1998 after 206 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.
- (no number) Sanofi-Winthrop Injector: named in the summary without a submission number

## Indications for use
The UltraSafe® Model C200 Injector with Needle Guard is designed to hold a sterile medication cartridge with needle in place while administering an injection. The guard is intended to protect the user from needie sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model C200 Injector is used with a standard Sanofi-Winthrop Carpuject® 2.0ml medication cartridge to deliver medication from the cartridge to the tissue of a patient, and is equipped with a shield that covers the needle during disposal. This device is used for a wide range of patients from children to aduits and for a wide range of clinical conditions.

Source page: https://510kreport.com/device/K972877
Methodology: https://510kreport.com/methodology