# K192230: MF Safecath

- Pathway: 510(k) (Traditional)
- Applicant: Medifirst Co., Ltd.
- Decided: Apr 23, 2020 after 251 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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 K013800 (2001). 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)
- K013800: Insyte, Angiocath, Insyte Autoguard, Angiocath Autoguard, Autoguard Pro, Intima, and Saf-T-Intima Intravascular Cathete, Becton Dickinson Infusion Therapy Systems, Inc. (2001) Summary page 4.

## Indications for use
MF SAFECATH, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Source page: https://510kreport.com/device/K192230
Methodology: https://510kreport.com/methodology