# K935067: Aquaplast

- Pathway: 510(k) (Traditional)
- Applicant: Wfr/Aquaplast Corp.
- Decided: May 26, 1994 after 218 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K022708: Klarity (2002), 3 descendants of its own
- K120335: Embrace Thermoplastic (2012), 2 descendants of its own
- K252174: AquaCast Mask (2025), 0 descendants of its own
- K192102: Thermoplastic Masks (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K935067
Methodology: https://510kreport.com/methodology