510(k) Report

510(k) · Cleared

Cleared

Sonic Palpometer

K060125510(k) TraditionalCleared Mar 16, 200657-day reviewClass I21 CFR 890.1615

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

Palpometer Systems, Inc. · IKE Transducer, Miniature Pressure

Cleared on Mar 16, 2006 after a 57-day review. The FDA summary names no predicate by number.

Decided
Mar 16, 2006
Review
57 days
Class
Class I
Product code
IKE
Recalls
None
Predicates
0

The FDA summary names no predicate by number.

FIG. 1 — Lineage of K060125Source: FDA 510(k) database · 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), 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.

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What was it cleared against?

The FDA summary names no predicate by 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.

How does its category compare?

All IKE devices

IKE Transducer, Miniature Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IKE

FDA has decided no IKE device since 2007.

Median 510(k) review, days · IKE

Too few IKE 510(k)s in any year since 2007 to give a median.

Recalls per year · IKE

No recall names IKE since 2007.

Adverse event reports per year · IKE

1in 2021

2021: 1
2007high 1 (2021) · low 0 (2007)2025

MAUDE reports naming product code IKE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and treatments that use digital palpation.

Indications for use as stated in the FDA summary.

Recent decisions in IKE

The IKE category page

  • K954670Pressore MonitorCleveland Medical Devices, Inc. · 1995
  • K915369The EqualizerAdvanced Rehabilitative Technology, Inc. · 1993
  • K915326Portable Limb Load Monitor (Bmllm-100)Bar Med Pty, Ltd. · 1992
  • K920091Iowa Oral Performance IsntrumentBreakthrough, Inc. · 1992
  • K915897FPLWrm Computers · 1992

https://510kreport.com/device/K060125 · printed Nov 4, 2026

Cite this page

510(k) Report. “K060125: Sonic Palpometer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060125

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026