Cleared Traditional

K950778 - MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER

K950778 is an FDA 510(k) clearance for MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER, manufactured by Shanghai Medifriend Medical Products Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXQ cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K950778 · Shanghai Medifriend Medical Products Co., Ltd. · Cardiovascular device
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Mar 1995
Decision
21d
Days
Class 2
Risk

K950778 is an FDA 510(k) clearance for the MEDIFRIEND PROFESSIONAL SPHYGMOMANOMETER. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Shanghai Medifriend Medical Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on March 14, 1995 after a review of 21 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shanghai Medifriend Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K950778

510(k) Number K950778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date March 14, 1995
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXQ Device Classification - Class 2, Special Controls

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 147
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K950778.
ANEROID AND MERCURIAL SPHYGMOMANOMETERS
K962655 · American Diagnostic Corp. · Jan 1997
ULTRACUFF BLOOD PRESSURE CUFF AND INFLATION BAG
K954282 · Statcorp, Inc. · Feb 1996
DEROYAL INDUSTRIS, INC. BLOOD PRESSURE CUFF
K953952 · Deroyal Industries, Inc. · Sep 1995
MINIMUS II
K942777 · Rudolf Riester GmbH & Co. KG · Jul 1994
HAND ANEROID SPHYGMOMANOMETER
K940493 · Welch Allyn, Inc. · Jul 1994
RI-MED
K925297 · Rudolf Riester GmbH & Co. KG · Jan 1994