# HCC: Device, Biofeedback

- Device class: 2; regulation: 21 CFR 882.5050; FDA's rule: 510(k) exempt
- FDA decisions: 172
- 510(k) review time 2021–2025: median 255 days (middle half 249–262)
- Recalls: 2 (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)
- 2007: 1
- 2008: 2
- 2010: 1
- 2011: 1
- 2013: 2
- 2015: 2
- 2017: 1
- 2018: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K903497: Flexcomp DSP & Procomp (1991), cited by 3
- K881416: Myotrac (1988), cited by 3
- K990538: Brainmaster 2E Module and Software Biofeedback Device (1999), cited by 3
- K020399: Resperate; Model RR-150 (2002), cited by 3
- K920038: Neurosearch-4 (1995), cited by 3
- K945826: J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software Applications (1995), cited by 2
- K914920: Biofeedback System/3 (1992), cited by 2
- K092675: Grindcare (2010), cited by 2
- K832714: Verimed Myoexorciser (1983), cited by 2
- K073557: Eeg Neuroamp, Model CS10137 (2008), cited by 2

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