Cleared Traditional

K811079 - SYPHGMOLOG

K811079 is the FDA 510(k) clearance for SYPHGMOLOG by Cardiodyne General, Inc.. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K811079 · Cardiodyne General, Inc. · Cardiovascular device
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Jun 1981
Decision
52d
Days
Class 2
Risk

K811079 is an FDA 510(k) clearance for the SYPHGMOLOG. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Cardiodyne General, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 12, 1981 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Cardiodyne General, Inc. devices

Submission Details

510(k) Number K811079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1981
Decision Date June 12, 1981
Days to Decision 52 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 125d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 34
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K811079.
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985
LME BLOOD PRESSURE MONITOR
K832017 · Litton Medical Electronics · Oct 1983
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · Honeywell, Inc. · Feb 1981
PRESSURE FUNCTION BLOCKS
K810172 · Honeywell, Inc. · Feb 1981