# K213855: Arrow Pressure Injectable Midline Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Arrow International, LLC Subsidiary of Teleflex Incorporated
- Decided: Sep 2, 2022 after 266 days
- Product code: PND (Midline Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K001901 (2000). 30 ancestors in all.
No later device cites it as a predicate yet.
4 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161313: ARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic Technology, Arrow International, Inc. (Subsidiary of Teleflex, Inc.) (2016) Summary page 4.

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2387-2026: Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffect

## Indications for use
The Arrow(R) Pressure Injectable Midline Catheter is indicated for short-term (< 30 days) peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media. The maximum pressure of pressure injector equipment used with the Arrow Pressure Injectable Midline Catheter may not exceed 300 psi (2068.4 kPa). The maximum pressure injection flow rate for the specific lumen being used for pressure injection is printed on the extension line hub.

Source page: https://510kreport.com/device/K213855
Methodology: https://510kreport.com/methodology