# K252438: Explant Express

- Pathway: 510(k) (Traditional)
- Applicant: Applied Medical Technology, Inc.
- Decided: Feb 3, 2026 after 186 days
- Product code: QVS (Breast Implant Suction Retrieval Device)
- Device class: 2
- Regulation: 21 CFR 878.4675
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN220082 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220082: Breast Implant Removal Device (BIRD), Gaylord Solutions, LLC (2023) Summary page 5.

## Indications for use
The Explant Express T M is a single patient, single use suction device used to assist in the removal of one intracapsular ruptured silicone breast implant. Not intended for en bloc removal. Not intended to remove residual silicone or be applied directly to tissue.

Source page: https://510kreport.com/device/K252438
Methodology: https://510kreport.com/methodology