# K023374: Groshong NXT Dual Lumen Picc Catheters

- Pathway: 510(k) (Abbreviated)
- Applicant: C.R. Bard, Inc.
- Decided: Dec 18, 2002 after 71 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: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K904558 (1991). 2 ancestors in all.
53 later devices descend from it; 3 cite it directly.
7 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K904558: Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val, Davol, Inc. (1991) Summary page 1.
- K926331: 3.0 FR Groshong Peripher Insert Cent Venous Cath, Bard Access Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K060341: Sherlock Tip Location System (TLS) (2006), 43 descendants of its own
- K063240: Sherlock TLS Stylet, Sherlock TLS Detector (2006), 42 descendants of its own
- K081625: Flowpicc Stylet (2008), 40 descendants of its own
- K081626: Flowpicc Console (2008), 39 descendants of its own
- K091324: Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System Stylet (2009), 38 descendants of its own

## Recalls of this device
- Aug 8, 2014 · Class II · Z-1271-2015: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of 
- Dec 20, 2005 · Not classified · Z-0544-06: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, 
- Dec 20, 2005 · Not classified · Z-0541-06: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, 
- Dec 20, 2005 · Not classified · Z-0543-06: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, 
- Dec 20, 2005 · Not classified · Z-0542-06: Multiple pages in the Instructions For Use booklet were missing print. Booklets were missing either pages 1,4,5,8,9,12,13,and 15, or 2,3,6,7,10,11,14, and 15. These pages contain product description, 

## Indications for use
The Groshong NXT PICC provides short (less than 30 days) or long (greater than 30 days) term peripheral access to the central venous system for intravenous therapy or blood sampling.

Source page: https://510kreport.com/device/K023374
Methodology: https://510kreport.com/methodology