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Curity Peakometer

by Kendall Research Center 510(k)

Active United States

510(k) K771655

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK771655 Date14 Oct 1977ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FFG
Device Class
Class II
Regulation
21 CFR Part 876.1800
Advisory Committee
Gastroenterology, Urology
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 Curity Peakometer is a non-electrical, disposable device used for measuring urine flow rate. It is designed to assist in the assessment of urinary function.

This device is classified as a class 2 medical device under regulation number 876.1800. It has received FDA 510(k) clearance under the number K771655.

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