510(k) Report

FDA product code · General and plastic surgery

Electrical Impedance Spectrometer

ONVClass II21 CFR 878.1820510(k) required1 decision since 20170 recalls

1 FDA decision since 2017. No recall names this code.

An electrical impedance spectrometer is a prescription device that measures and analyzes electrical impedance properties of a skin lesion. The device is intended for use by a physician trained in the clinical diagnosis and management of skin cancer as an adjunctive device following identification of a suspicious skin lesion. The output given by the device is intended to be used in combination with clinical and…

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

FIG. A — Illustration, general and plastic surgery panel

Twenty years of ONV at a glance: how often FDA decides these devices, how long 510(k) reviews take, how often they are recalled, and how many adverse event reports name the code.

FDA decisions per year · ONV

1in 2025

2017: 12018: 22019: 12020: 12025: 12026 (partial year): 1
2007high 2 (2018) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ONV

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

Recalls per year · ONV

No recall names ONV since 2007.

Adverse event reports per year · ONV

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code ONV, 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
20171—00
20182—00
20191—01
20201—00
20210—00
20220—00
20230—00
20240—00
20251—00
20261—0—
FIG. 1 — ONV by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports, MAUDE · Data through Oct 25, 2026

Planning a device in ONV? A 510(k) Report ranks candidate predicates in this code by lineage, citations and recall history, with the review-time outlook.

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