Cleared Traditional

CONPHAR DESK TOP MERCURY SPHYGMOMAN (K801188) - FDA 510(k) Clearance

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

K801188 · Conphar, Inc. · Cardiovascular device
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Jun 1980
Decision
21d
Days
Class 2
Risk

K801188 is an FDA 510(k) clearance for the CONPHAR DESK TOP MERCURY SPHYGMOMAN. Classified as Blood Pressure Cuff (product code DXQ), Class II - Special Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 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 Conphar, Inc. devices

Submission Details

510(k) Number K801188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1980
Decision Date June 09, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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 55
Devices cleared under the same product code (DXQ) and FDA review panel - the closest regulatory comparables to K801188.
THIGH CUFF: X-LARGE CUFF
K813323 · Abco Dealers, Inc. · Dec 1981
TRONZO HIP
K812946 · Biomet, Inc. · Nov 1981
CONPHAR DELUXE ANEROID SPHYGMOMANOMETER
K801186 · Conphar, Inc. · Jun 1980
CONPHAR WALL MODEL MERCURY SPHYGMOMAN.
K801182 · Conphar, Inc. · Jun 1980
ABCO MERCURIAL SPHYGMOMANOMETER
K800236 · Abco Dealers, Inc. · Feb 1980
ANEROID SPHYMOMANOMETER
K792355 · Abco Dealers, Inc. · Dec 1979