# K904558: Dual Lumen 5 FR Perip Cent Ven Cath W/Groshong Val

- Pathway: 510(k) (Traditional)
- Applicant: Davol, Inc.
- Decided: Feb 11, 1991 after 129 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
No predicates in its family tree.
54 later devices descend from it; 1 cites it directly.
7 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K023374: Groshong NXT Dual Lumen Picc Catheters (2002), 53 descendants of its own
- 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

Source page: https://510kreport.com/device/K904558
Methodology: https://510kreport.com/methodology