# K954970: Stopcock & Luer Lock Plug

- Pathway: 510(k) (Traditional)
- Applicant: Medex, Inc.
- Decided: Apr 22, 1996 after 175 days
- Product code: FMG (Stopcock, I.V. Set)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861563 (1986). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K861563: Vitaguard Percutaneous Infection Control Kit, Vitaphore Corp. (1986) Summary page 1.
- (no number) Medex, Inc.’s pre-amendment stopcock MX531-1L: named in the summary without a submission number
- (no number) Medex, Inc.’s pre-amendment Luer lock plug MX491: named in the summary without a submission number

## Most influential descendants
- K053405: Bacstop (2006), 2 descendants of its own
- K082106: Elcam Antimicrobial Closed Stopcocks (DSS and TSS) (2008), 0 descendants of its own
- K073396: Antimicrobial Ultrasite Value, Ultrasite AG (2008), 0 descendants of its own

## Recalls of this device
- Nov 10, 2023 · Class II · Z-0745-2024: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead

## Indications for use
A stopcock is a typical element of fluid or drug administration. It is used to control/direct fluid flow and permit fluid access to the patient. A Luer lock plug is used to terminate any open Luer port. The silver antimicrobial additive will enhance performance by minimizing the possibility the devices will be microbially compromised.

Source page: https://510kreport.com/device/K954970
Methodology: https://510kreport.com/methodology