# K231286: Chemfort® Catheter Adaptor

- Pathway: 510(k) (Traditional)
- Applicant: Simplivia Healthcare, Ltd.
- Decided: Aug 2, 2023 after 90 days
- Product code: ONB (Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System)
- 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: 10 generations back to K883614 (1988). 36 ancestors in all.
No later device cites it as a predicate yet.
3 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180489: TEVADAPTOR Closed Drug Reconstitution and Transfer System, Teva Medical Ltd., Migada Plant (2018) Summary page 4.

## Indications for use
Chemfort® Catheter Adaptor is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® Catheter Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

Source page: https://510kreport.com/device/K231286
Methodology: https://510kreport.com/methodology