# OAB: Low Energy Direct Current Thermal Ablation System

- Device class: 2; regulation: 21 CFR 878.4400; FDA's rule: 510(k) required
- FDA decisions: 15
- 510(k) review time 2021–2025: median 203 days (middle half 111–271)
- Recalls: 3 (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)
- 2006: 1
- 2008: 2
- 2011: 1
- 2015: 1
- 2019: 1
- 2022: 1
- 2023: 1
- 2024: 4
- 2026: 3

## Most-cited predicates
- K183385: NanoKnife System (2019), cited by 4
- K060054: Oncobionic System (2006), cited by 3
- K102329: Nanoknife System (2011), cited by 2
- K212871: Aliya (TM) System, Aliya (TM) Generator, Aliya (TM) Needle, Aliya (TM) Electrode (2022), cited by 2
- K150089: NanoKnife System (2015), cited by 1
- K233884: INUMI™ Flex Needle (2024), cited by 1
- K242687: NanoKnife Generator (H78720300301US0); NanoKnife Single Electrode Activation Probe, 15 cm (H787204001090); NanoKnife Single Electrode Activation Probe, 25 cm (H787204001100); NanoKnife Single Electrode Probe Spacer (H787204003010) (2024), cited by 1
- K080376: Oncobionic System (2008), cited by 1
- K080202: Oncobionic System with 6 Probe Output (2008), cited by 1

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