# K981318: Dual Luer Lock Cap

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Apr 22, 1998 after 12 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medex Male/Female Luer Lock Plug: named in the summary without a submission number
- (no number) B. Braun Blue Cap Dual Function Lock Lock Plug: named in the summary without a submission number
- (no number) Abbott Male/Female Sterile Cap: named in the summary without a submission number

## Most influential descendants
- K093229: Catheter Connections Dualcap (2010), 8 descendants of its own
- K101385: Dual Luer Lock Cap, Model 2C6250 (2010), 3 descendants of its own
- K113842: Catheter Connections' Dualcap Solo (2012), 2 descendants of its own
- K142806: DualCap (2015), 1 descendant of its own
- K123065: Catheter Connections Dualcap Solo (2012), 1 descendant of its own

## Indications for use
Baxter’s Dual Luer Lock Cap is intended for use as a cap for male or female luer ports on medical devices such as manifolds, stopcocks or sets.

Source page: https://510kreport.com/device/K981318
Methodology: https://510kreport.com/methodology
