# K972900: Ultrasafe Model T200 Injector

- Pathway: 510(k) (Traditional)
- Applicant: Safety Syringes, Inc.
- Decided: Feb 26, 1998 after 204 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) Wyeth TUBEX® Injector: named in the summary without a submission number

## Indications for use
The UltraSafe® Model T200 Injector with Needle Guard is designed to hold a TUBEX® Sterile Cartridge-Needle Unit 2.5 ml. in place while administering an injection. The guard is intended to protect the user from needle sticks after injection and during disposal of the needle cartridge unit. The UltraSafe® Model T200 Injector is used with a Tubex® Sterile Cartridge-Needle Unit 2.5 mi. 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 adults and for parenteral methods of administration.

Source page: https://510kreport.com/device/K972900
Methodology: https://510kreport.com/methodology