# OTJ: Laparoscopic Single Port Access Device

- Device class: 2; regulation: 21 CFR 876.1500; FDA's rule: 510(k) required
- FDA decisions: 11
- 510(k) review time 2021–2025: median 261 days (middle half 225–328)
- Recalls: 0 (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)
- 2010: 1
- 2011: 2
- 2012: 3
- 2016: 2
- 2021: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K110004: Asc Triport+ Laparoscopic Access Device (2011), cited by 3
- K112196: Octotmport (2011), cited by 1
- K101794: Asc Triport Laparoscopic Access Device Model TPRT-02-01 (WA58000T), Asc Quadport Laparoscopic Asscess Device QPRT-01 (WA (2010), cited by 1

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