# LCJ: Tissue Expander And Accessories

- Device class: U; regulation: 21 CFR —; FDA's rule: 510(k) required
- FDA decisions: 55
- 510(k) review time 2021–2025: median 299 days (middle half 77–491)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2013: 1
- 2014: 3
- 2015: 2
- 2016: 3
- 2018: 3
- 2023: 3
- 2024: 1
- 2025: 2
- 2026: 1

## Most-cited predicates
- K130813: Mentor CPX 4 Breast Tissue Expanders and Mentor CPX 4 with Suture Tabs Breast Tissue Expanders (2013), cited by 4
- K862203: Mcghan Magna-Site (TM) Tissue Expander (1986), cited by 2
- K161176: ARTOURA Breast Tissue Expanders with Smooth Surface (2016), cited by 2
- K070303: Silicone Tissue Expander (2007), cited by 2
- K152496: CPX 4 Breast Tissue Expander (2016), cited by 2
- K143354: Natrelle 133 Plus Tissue Expander (2015), cited by 2
- K870754: Mcghan Tissue Expander Fill System (1987), cited by 1
- K102806: Natrelle 133 Tissue Expander with Suture Tabs (2011), cited by 1
- K843704: Mcghan Tissue Expander (1984), cited by 1
- K011500: Mentor Contour Profile Tissue Expander (2001), cited by 1

Source page: https://510kreport.com/product-code/LCJ
Data by year (CSV): https://510kreport.com/product-code/LCJ.csv