510(k) · Cleared
ClearedVsa 3000 Vibratoryn Sensory Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eare Consulting Service · LLN Device, Vibration Threshold Measurement
Cleared on Apr 25, 1997 as substantially equivalent to K863607 (Sensortek, Inc., 1986) and 1 other predicate after a 98-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- Apr 25, 1997
- Review
- 98 days
- Class
- Class I
- Product code
- LLN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K863607 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK863607 Vibratron II, Vibration Sensitivity TesterSensortek, Inc. · 1986
- This deviceK970180 Vsa 3000 Vibratoryn Sensory AnalyzerEare Consulting Service · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K863607 | Vibratron II, Vibration Sensitivity Tester | Sensortek, Inc. | 1986 | — |
| 0 (this device) | K970180 | Vsa 3000 Vibratoryn Sensory Analyzer | Eare Consulting Service | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K863607 | Vibratron II, Vibration Sensitivity TesterSummary page 4…Other commercially available devices: Bio-thesiometer - Bio-Medical Instruments Co. avallable for over 50 years. Vibraton II, Vibration Sensitivity Tester - Sensortek - K863607 approved 1986 . Case IV - WR Medical Electronics Co. - K910624 approved in 1993 The VSA 3000 - Vibratory Sensory Analyzer is a… | 1986 |
| * | K910624 | Case IV Computer Aided Sensory Evaluator Version 4Summary page 4…cal Instruments Co. avallable for over 50 years. Vibraton II, Vibration Sensitivity Tester - Sensortek - K863607 approved 1986 . Case IV - WR Medical Electronics Co. - K910624 approved in 1993 The VSA 3000 - Vibratory Sensory Analyzer is a computerized device for the quantitative assessment of large ner… | 1992 |
| * | — | Bio-thesiometer - Bio-Medical Instruments Co. Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All LLN devicesLLN Device, Vibration Threshold Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLN
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LLN
Too few LLN 510(k)s in any year since 2007 to give a median.
Recalls per year · LLN
No recall names LLN since 2007.
Adverse event reports per year · LLN
No MAUDE report names LLN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For use in the measurement of vibratory thresholds, or sensibility, in clinical situations where various néuropathiies riiay exist.°
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970180 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970180: Vsa 3000 Vibratoryn Sensory Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970180
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026