# FNL: Bed, Ac-Powered Adjustable Hospital

- Device class: 2; regulation: 21 CFR 880.5100; FDA's rule: 510(k) exempt
- FDA decisions: 70
- 510(k) review time 2021–2025: median 261 days (middle half 261–261)
- Recalls: 110 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 1991: 1
- 1992: 2
- 1993: 8
- 1994: 2
- 1995: 6
- 1996: 4
- 1997: 8
- 1998: 2
- 2010: 1
- 2021: 1

## Most-cited predicates
- K103536: Ibed Wireless with Ibed Awareness (2010), cited by 3
- K963701: Soma Safe Enclosure (1997), cited by 3
- K922352: The Advance Series From Hill-Rom (1992), cited by 2
- K925576: Burke Bariatric Treatment System II (1993), cited by 1
- K964246: Novabed Patient Transfer System (1997), cited by 1
- K962942: Totalcare (1997), cited by 1
- K925534: Full/Semi Electric Home Care Bed (1993), cited by 1
- K915437: Critical Care Hospital Bed (Icu/Ccu) (1992), cited by 1

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