# K042126: PICC

- Pathway: 510(k) (Special)
- Applicant: Arrow Intl., Inc.
- Decided: Aug 27, 2004 after 21 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 4 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K930129 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
2 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K930129: Arrow Picc-Peripherally Inserted Central Catheter, Arrow Intl., Inc. (1994) Summary page 1.
- K003006: Two-Lumen Picc with Blue Flextip Catheter and Integral Needle Protection, Arrow Intl., Inc. (2000) Summary page 1.

## Recalls of this device
- Apr 21, 2026 · Class I · Z-2378-2026: 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
- Aug 27, 2015 · Class II · Z-2825-2015: Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled due to compromised sterility of the outer barrel, Arrow purchased recalled items that were packaged with certain products.
- Jul 30, 2015 · Class II · Z-2462-2015: the catheter peel-away component hub tabs may prematurely detach. One injury reported.
- Feb 11, 2009 · Not classified · Z-1503-2009: Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

## Indications for use
A Peripherally inserted Central Catheter permits venous access to the central circulation through a peripheral vein. It offers an alternative method of intravenous therapy for select adult and pediatric patients.

Source page: https://510kreport.com/device/K042126
Methodology: https://510kreport.com/methodology