# K130518: Mini-Midline Extended Dwell Safety Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Luther Needlesafe Products, Inc.
- Decided: Apr 30, 2013 after 62 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: 7 generations back to K932323 (1993). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121073: Powerglide Midline Catheter, C.R. Bard, Inc. (2012) Summary page 1.
- K112347: Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge, Vascular Pathways, Inc. (2011) Summary page 2.
- K110443: BD Insyte Autoguard BC, Becton, Dickinson & CO (2011)

## Indications for use
The Mini-MidlineTm Extended Dwell Safety Catheter is inserted into a patient's vascular system for short term use (< 30 days) to sample blood or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure.

Source page: https://510kreport.com/device/K130518
Methodology: https://510kreport.com/methodology