# ILK: Transport, Patient, Powered

- Device class: 2; regulation: 21 CFR 890.5150; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 161 days (middle half 144–177)
- 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)
- 2002: 1
- 2003: 7
- 2008: 1
- 2009: 1
- 2010: 2
- 2011: 1
- 2012: 3
- 2014: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K970927: Bruno Electra-Ride Iii Stairway Elevator System (1997), cited by 2
- K921648: Bruno Electra-Ride Stair-Way Elevator System (1992), cited by 2
- K103122: C-Max, C-Max U1, C-Max U1 160KG, C-Max U2, C-Max U2 160KG, S-Max, S-Max Aviation, S-Max Sella, S-Max Sella 160KG (2010), cited by 2
- K033752: Bruno Electra-Ride Stairway Elevator System. Model Sre-1540 (2003), cited by 2
- K130864: C-Max+ (Plus) (2014), cited by 1
- K033438: Bruno Electra-Ride Elite, Model Sre-2000 (2003), cited by 1
- K113308: Bruno Elan Stairway Elevator (2012), cited by 1

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