# K970180: Vsa 3000 Vibratoryn Sensory Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Eare Consulting Service
- Decided: Apr 25, 1997 after 98 days
- Product code: LLN (Device, Vibration Threshold Measurement)
- Device class: 1
- Regulation: 21 CFR 882.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863607 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863607: Vibratron II, Vibration Sensitivity Tester, Sensortek, Inc. (1986) Summary page 4.
- K910624: Case IV Computer Aided Sensory Evaluator Version 4, Wr Medical Electronics Co. (1992) Summary page 4.
- (no number) Bio-thesiometer - Bio-Medical Instruments Co.: named in the summary without a submission number

## Indications for use
For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various néuropathiies riiay exist.°

Source page: https://510kreport.com/device/K970180
Methodology: https://510kreport.com/methodology