# K252402: Midline Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Terumo Medical Products (Hangzhou) Co., Ltd.
- Decided: Dec 18, 2025 after 140 days
- Product code: PND (Midline Catheter)
- 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: 10 generations back to K932323 (1993). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162377: PowerGlide Pro Midline Catheter, C.R. Bard, Inc. (2016) Summary page 6.

## Indications for use
The Midline Catheter is indicated for insertion into a patient's vascular system for short-term use (<30 days) to sample blood or administer fluids intravenously. It may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Midline Catheter is suitable for use with power injectors.

Source page: https://510kreport.com/device/K252402
Methodology: https://510kreport.com/methodology