# LLN: Device, Vibration Threshold Measurement

- Device class: 1; regulation: 21 CFR 882.1200; FDA's rule: 510(k) exempt
- FDA decisions: 13
- 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)
- 1984: 1
- 1986: 2
- 1987: 1
- 1992: 2
- 1994: 1
- 1997: 3
- 2001: 1
- 2003: 1
- 2009: 1

## Most-cited predicates
- K853608: Neurometer (1986), cited by 4
- K843486: Vibrameter (1984), cited by 2
- K910624: Case IV Computer Aided Sensory Evaluator Version 4 (1992), cited by 1
- K964815: AP-4000, Air Pulse Sensory Stimulator (1997), cited by 1
- K863607: Vibratron II, Vibration Sensitivity Tester (1986), cited by 1
- K010981: Gsa Genito Sensory Analyzer (2001), cited by 1

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