Cleared Traditional

CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER (K972899) - FDA 510(k) Clearance

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

K972899 · Cypress Medical Products, Ltd. · Cardiovascular device
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Jul 1998
Decision
335d
Days
Class 2
Risk

K972899 is an FDA 510(k) clearance for the CYPRESS MEDICAL PRODUCTS ANEROID SPHYGMOMANOMETER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Cypress Medical Products, Ltd. (Mc Henry, US). The FDA issued a Cleared decision on July 7, 1998 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cypress Medical Products, Ltd. devices

Submission Details

510(k) Number K972899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 1997
Decision Date July 07, 1998
Days to Decision 335 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
210d slower than avg
Panel avg: 125d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXQ Blood Pressure Cuff
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1120
Definition A Blood Pressure Cuff Is A Device That Has An Inflatable Bladder In An Elastic Sleeve (cuff) With A Mechanism For Inflating The Bladder. The Cuff Is Used To Determine A Subject's Blood Pressure.
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.

Regulatory Peers - DXQ Blood Pressure Cuff

All 197
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