CleanCuff

No FDA recalls found in the data synced 22 Oct 2026.

Full name

Cleancuff(Tm)

510(k) Number

K931087 ↗

FDA Product Code

DXQ

Device Class

Class II

Regulation

21 CFR Part 870.1120

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Medcuff

  Class II

  FDA 510(k) K942488 Active Cleared 23 Aug 1994

• Windsurfer Open recall

  Class II

  FDA 510(k) K050561 Active Cleared 4 May 2005

• The Midview-Medcon's Dicom Viewer

  Class II

  FDA 510(k) K971181 Active Cleared 29 Jul 1997

• Horizon Cardiology ECG-Mckesson's ECG Management System, Model 1.0

  Class II

  FDA 510(k) K061905 Active Cleared 8 Nov 2006

• TCS-Medcon Telecardiology System

  Class II

  FDA 510(k) K974679 Active Cleared 23 Mar 1998

• What is the CleanCuff used for in clinical settings?

  The CleanCuff is designed as a component of sphygmomanometers to measure blood pressure accurately. It works by inflating to temporarily block arterial flow and then deflating to determine systolic and diastolic pressures. This aids in cardiovascular monitoring and diagnosis, helping clinicians assess patient health and detect conditions like hypertension.

• Is the CleanCuff single-use or reusable?

  The CleanCuff can be supplied as either single-use or reusable, depending on the specific model or configuration chosen by the manufacturer. This flexibility allows healthcare providers to select the option that best fits their workflow, hygiene protocols, and cost considerations.

• What regulatory approval does the CleanCuff hold?

  The CleanCuff is cleared by the FDA under the 510(k) pathway, with clearance number K931087. It is classified under the product code DXQ and falls under the Cardiovascular advisory committee. This clearance indicates it is deemed substantially equivalent to a legally marketed device.

• Where can the CleanCuff be used?

  The CleanCuff is intended for use in a variety of settings, including hospitals, clinics, and home environments. Its versatility makes it suitable for both professional healthcare providers and patients monitoring their own blood pressure.

• Does the CleanCuff come with specific sizing details?

  The provided data does not specify sizing details for the CleanCuff. Users should refer to the manufacturer’s documentation or consult with Med-Con, Inc. for information on available sizes to ensure proper fit and accurate blood pressure readings.