# K941851: Dual Lumen Catheter (DLC) Tray

- Pathway: 510(k) (Traditional)
- Applicant: Neostar Medical Technologies, Inc.
- Decided: Mar 13, 1995 after 333 days
- Product code: KOC (Accessories, Blood Circuit, Hemodialysis)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K963446: Kendall Dual Lumen Catheter (1997), 2 descendants of its own
- K063355: D-Line Catheter ST, Double Lumen ST; Extra Flow (2007), 1 descendant of its own
- K102833: Disposable Hemodialysis Access Catheter Sets (2011), 0 descendants of its own
- K952660: Braun Hemodialysis Catheter (1996), 0 descendants of its own

## Recalls of this device
- May 28, 2004 · Not classified · Z-1029-04: The products have a potential defective seal that closes the product's OUTER POUCH. The surface of the INNER TRAY may no longer be sterile.

Source page: https://510kreport.com/device/K941851
Methodology: https://510kreport.com/methodology