# K192866: Chemfort CSTD

- Pathway: 510(k) (Abbreviated)
- Applicant: Simplivia Healthcare, Ltd.
- Decided: May 7, 2020 after 213 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K883614 (1988). 35 ancestors in all.
3 later devices descend from it; 3 cite it directly.
3 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141448: Tevadaptor Closed Drug Reconstitution and Transfer System, Teva Medical Ltd., Migada Plant (2015) Summary page 5.

## Most influential descendants
- K253033: Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor (2025), 0 descendants of its own
- K251411: Chemfort Female Luer Lock Adaptor (2025), 0 descendants of its own
- K210707: OnGuard2 Chemfort Closed Administration (CADM) (2021), 0 descendants of its own

## Recalls of this device
- Mar 8, 2022 · Class II · Z-1057-2022: Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

## Indications for use
Chemfort is a 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, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort 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/K192866
Methodology: https://510kreport.com/methodology