# K982368: Manifold with Extension Set

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Cross Intl.
- Decided: Jul 31, 1998 after 24 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: 1 generation back to K962581 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962581: Stopcock Manifold Gangs, Baxter Healthcare Corp (1996). Our OCR of the scanned summary read K962531, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Baxter Stopcock Manifold Gangs”.
- (no number) Medex Guide-Flo Stopcock Manifold Gangs: named in the summary without a submission number

## Indications for use
The Interpore Cross International Manifold with Extension Set is intended to provide multiple access sites into a common fluid path for blood, plasma or solutions. The luer connectors on either end of the stopcock gang allow connection to the Extension Set for fluid transfer (i.e., blood, plasma, or solution).

Source page: https://510kreport.com/device/K982368
Methodology: https://510kreport.com/methodology