LogoFDA 510(k) Search
K Number
K031416
Device Name
CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF
Manufacturer
CLEAR MEDICAL, INC.
Date Cleared
2003-07-15

(71 days)

Product Code
DXQ
Regulation Number
870.1120
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ClearMedical Blood Pressure Cuff is indicated for use in manual measurement and automatic non-invasive blood pressure (BP) monitoring by properly trained personnel. Complete inflation systems are designed for use with manometers during manual BP measurement The ClearMedical Blood Pressure Cuff is intended as a single patient use item.

Device Description

Not Found

AI/ML Overview

This is a medical device clearance letter from the FDA for the ClearMedical Blood Pressure Cuff (K031416). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

Medical device clearance letters like this one typically confirm substantial equivalence based on comparisons to existing devices, review of design specifications, and performance data provided by the manufacturer. They summarize the FDA's decision but do not usually include the detailed study results or the specific acceptance criteria themselves. These details would be found in the manufacturer's 510(k) submission to the FDA.

Therefore, I cannot provide the requested information from the given text.

To be clear, the sections of your request that cannot be answered from this document are:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
  4. Adjudication method
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 870.1120 Blood pressure cuff.

(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).