# K853014: Mcghan Tissue Expander Fill Kit

- Pathway: 510(k) (Traditional)
- Applicant: Mcghan Medical Corp.
- Decided: Sep 18, 1985 after 63 days
- Product code: LCJ (Tissue Expander And Accessories)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K131692: Blossom Saline Delivery Assist Device (2014), 0 descendants of its own

## Recalls of this device
- Sep 26, 2023 · Class II · Z-0134-2024: Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to ha

Source page: https://510kreport.com/device/K853014
Methodology: https://510kreport.com/methodology