# K211204: SafePort (TM) Manifold (or Stopcock)

- Pathway: 510(k) (Traditional)
- Applicant: Elcam Medical Acal
- Decided: Sep 15, 2022 after 511 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: 3 generations back to K862691 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060231: Closed Swabable Stopcock and Minimal Residual Volume Luer-Activated Swabable-Stopcock, Elcam Medical Acal (2006) Summary page 4.

## Indications for use
SafePort(TM) Manifold (or Stopcock) is a one or more multiple ports product, which is indicated to serve as a flow control and a conduit device for I.V fluids delivery to the patient's vascular system. The product is intended for delivering I.V drugs or fluids, allowing gravity feed, sampling, transfusion, bolus injection and elimination of reflux of fluids during operation.

Source page: https://510kreport.com/device/K211204
Methodology: https://510kreport.com/methodology