510(k) Report

510(k) · Cleared

Cleared

Vibrameter

K843486510(k) TraditionalCleared Dec 24, 1984109-day reviewClass I21 CFR 882.1200

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Somedic AB · LLN Device, Vibration Threshold Measurement

Cleared on Dec 24, 1984 after a 109-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Dec 24, 1984
Review
109 days
Class
Class I
Product code
LLN
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2014: 1 descendant cleared19801990200020102020
  1. This deviceK843486 VibrameterSomedic AB · 1984
  2. Descendant · cites it directly · 0 of its ownK141208 Dynamic Neuroscreening DeviceProsenex · 2014
  3. Descendant · cites it directly · 0 of its ownK030829 VPT MeterXilas Medical, Inc. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K141208Dynamic Neuroscreening DeviceProsenex · 2014 · cites it directly0descendants
  • K030829VPT MeterXilas Medical, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K843486VibrameterSomedic AB1984—
+1K141208Dynamic Neuroscreening DeviceProsenex2014—
+1K030829VPT MeterXilas Medical, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
201410
FIG. 1 — Lineage of K843486, 1984–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K141208Dynamic Neuroscreening DeviceProsenex20140
K030829VPT MeterXilas Medical, Inc.20030

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?

  • Of its descendants, K141208 (Prosenex, 2014) has gone furthest, with 0 descendants of its own.

How does its category compare?

All LLN devices

LLN Device, Vibration Threshold Measurement: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LLN

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in LLN

The LLN category page

  • K072882Pain Vision, Model PS-2100Osachi Co., Ltd. · 2009
  • K030829VPT MeterXilas Medical, Inc. · 2003
  • K010981Gsa Genito Sensory AnalyzerMedoc Ltd. Advanced Medical Systems · 2001
  • K964622Medi-DX 7000Neuro-Diagnostic Assoc. · 1997
  • K964815AP-4000, Air Pulse Sensory StimulatorPentax Precision Instrument Corp. · 1997

https://510kreport.com/device/K843486 · printed Nov 5, 2026

Cite this page

510(k) Report. “K843486: Vibrameter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K843486

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026