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Icertainty

by Rfpi

510(k) K181269

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181269 Date14 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DPW
Device Class
Class II
Regulation
21 CFR Part 870.2100
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The iCertainty is a cardiovascular blood flowmeter designed to provide real-time imaging of blood flow and perfusion in vascular structures and critical tissues. It functions as a diagnostic tool to assist clinicians during surgical procedures.

This device is classified as a Class II medical device under regulation number 870.2100. It has received FDA 510(k) clearance under the reference number K181269.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary function of the iCertainty device?

    The iCertainty is a cardiovascular blood flowmeter designed to assist clinicians during surgical procedures by providing real-time imaging of blood flow and perfusion in vascular structures and critical tissues.

  • What is the regulatory status of the iCertainty flowmeter?

    The iCertainty is classified as a Class II medical device under regulation number 870.2100 and has received FDA 510(k) clearance under reference number K181269.

  • Which medical specialty is this device intended for?

    The iCertainty is intended for use within the cardiovascular specialty, as indicated by its classification under the cardiovascular advisory committee and its designation as a cardiovascular blood flowmeter.