# K960431: Pressure Stopcock/Manifold

- Pathway: 510(k) (Traditional)
- Applicant: Scientific Device Manufacturer, LLC
- Decided: Oct 29, 1996 after 272 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Namic stopcock/manifold: named in the summary without a submission number
- (no number) Medex stopcock/manifold: named in the summary without a submission number
- (no number) Spectra Medical stopcock/manifold: named in the summary without a submission number

## Most influential descendants
- K123084: Disposable High Pressure Stopcock/Manifold Model HP Stopcock, MP Stopcock, HP Manifold, PHP Manifold (2013), 1 descendant of its own
- K242255: Qitexio® 4-Way Stopcock (QIT014) (2025), 0 descendants of its own

## Indications for use
This device provides additional access ports into a standard angiographic fluid delivery system and can be used in conjunction with syringes and other accessories where angiographic injection is indicated. This product’s medium/high pressure designation does not preclude its use for low pressure modalities.

Source page: https://510kreport.com/device/K960431
Methodology: https://510kreport.com/methodology