# K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold

- Pathway: 510(k) (Traditional)
- Applicant: Elcam Medical Acal
- Decided: May 23, 2013 after 234 days
- Product code: FMG (Stopcock, I.V. Set)
- 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
Longest line of descent: 4 generations back to K862691 (1986). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111016: Safeport Manifold (TM) (or Stopcock), Elcam Medical Acal (2011) Summary page 2.
- K960431: Pressure Stopcock/Manifold, Scientific Device Manufacturer, LLC (1996) Summary page 2.

## Most influential descendants
- K242255: Qitexio® 4-Way Stopcock (QIT014) (2025), 0 descendants of its own

## Indications for use
Elcam's High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High Pressure Manifolds are intended for single use only.

Source page: https://510kreport.com/device/K123084
Methodology: https://510kreport.com/methodology