Cleared Traditional

K032821 - HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032821 · Hygia Health Services, Inc. · Cardiovascular device
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Dec 2003
Decision
91d
Days
Class 2
Risk

K032821 is an FDA 510(k) clearance for the HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF. Classified as Reprocessed Blood Pressure Cuff (product code NPP), Class II - Special Controls.

Submitted by Hygia Health Services, Inc. (Birmingham, US). The FDA issued a Cleared decision on December 5, 2003 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1120 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Hygia Health Services, Inc. devices

Submission Details

510(k) Number K032821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2003
Decision Date December 05, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 125d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NPP Reprocessed Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition The Intended Use For The Reprocessed/reused Blood Pressure Cuff Is Use In Manual Measurement And Automatic Non-invasive Blood Pressure Monitoring By Properly Trained Personnel. Complete Inflation Systems Are Designed For Use With Manometers During Manual Bp Measurement.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.