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Cleen-Able

by Vital Signs, Inc. 510(k)

Active United States

510(k) K994044

Overview

The CLEEN-ABLE Blood Pressure Cuff is a non-invasive blood pressure monitoring device classified as a sphygmomanometer cuff. It is designed to measure arterial blood pressure in adults and children by inflating a cuff around the upper arm to occlude the brachial artery, enabling indirect blood pressure assessment.

This device is intended for use with manual and automatic sphygmomanometers by trained personnel. Supplied as a non-sterile, reusable item, it is regulated under FDA 510(k) clearance (K994044) and falls under Product Code DXQ, classified as a Class II medical device. Storage and handling should comply with manufacturer guidelines to maintain accuracy and hygiene.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK994044 Date25 Feb 2000ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
DXQ
Device Class
Class II
Regulation
21 CFR Part 870.1120
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What types of blood pressure monitors can the CLEEN-ABLE Blood Pressure Cuff be used with, and who should operate it?

    The CLEEN-ABLE Blood Pressure Cuff is designed for use with both manual and automatic sphygmomanometers. It is intended for trained personnel, such as healthcare providers, to perform non-invasive blood pressure measurements in adults and children.

  • Is the CLEEN-ABLE Blood Pressure Cuff reusable or single-use, and how should it be maintained?

    The CLEEN-ABLE Blood Pressure Cuff is a reusable, non-sterile device. Proper storage and handling are required to maintain its accuracy and hygiene, following the manufacturer’s guidelines to ensure reliable performance over time.

  • What regulatory pathway was followed for the CLEEN-ABLE Blood Pressure Cuff, and what classification does it hold?

    The CLEEN-ABLE Blood Pressure Cuff underwent FDA 510(k) clearance through a traditional review process, determined to be substantially equivalent to a predicate device. It is classified as a Class II medical device under Product Code DXQ and was reviewed by the FDA’s Cardiovascular Advisory Committee.

  • Can the CLEEN-ABLE Blood Pressure Cuff be used on both adults and children, and how is its size range determined?

    Yes, the CLEEN-ABLE Blood Pressure Cuff is designed for use on both adults and children. While the exact size range isn’t specified in the data, its design as an upper-arm cuff suggests it is intended to accommodate a variety of arm circumferences, typically measured in standard cuff sizes (e.g., pediatric, adult small, adult large).