# K253033: Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

- Pathway: 510(k) (Special)
- Applicant: Simplivia Healthcare, Ltd.
- Decided: Oct 21, 2025 after 29 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)
- K192866: Chemfort CSTD, Simplivia Healthcare, Ltd. (2020) Summary page 5.

## Indications for use
Chemfort® 28-day 20 mm Vial 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 preparation, reconstitution, compounding and administration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® 28-day 20 mm Vial Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 28 days or 10 activations.

Source page: https://510kreport.com/device/K253033
Methodology: https://510kreport.com/methodology