# K222929: ToxiSeal Vial Adapter with External Balloon

- Pathway: 510(k) (Traditional)
- Applicant: Epic Medical Pte., Ltd.
- Decided: Jan 11, 2024 after 472 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: 7 generations back to K883614 (1988). 13 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123213: BD Phaseal Closed System Transfer Device, Becton, Dickinson & CO (2013) Summary page 5.

## Most influential descendants
- K241476: ToxiSeal™ Vial Adaptor with External Flip Balloon (2024), 1 descendant of its own
- K241823: ToxiSeal™ Vial Adaptor (2024), 0 descendants of its own

## Indications for use
The ToxiSealTM Vial Adaptor with External Balloon mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

Source page: https://510kreport.com/device/K222929
Methodology: https://510kreport.com/methodology