Cleared Traditional

K791636 - ACCUNAMIC

K791636 is the FDA 510(k) clearance for ACCUNAMIC by Sorensen Research. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K791636 · Sorensen Research · Cardiovascular device
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Oct 1979
Decision
44d
Days
Class 2
Risk

K791636 is an FDA 510(k) clearance for the ACCUNAMIC. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Sorensen Research (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Sorensen Research devices

Submission Details

510(k) Number K791636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1979
Decision Date October 04, 1979
Days to Decision 44 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
81d faster than avg
Panel avg: 125d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 31
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K791636.
CATHDAMP
K810661 · Medline Industries, Inc. · Mar 1981
CARDIOSCOPE J200
K802179 · Telectronics, Inc. · Nov 1980
ACCUDYNAMIC
K801048 · Sorensen Research · May 1980
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A
K771361 · Hewlett-Packard Co. · Aug 1977
MODEL DA-53 PRESSURE GUAGE ISOLATOR
K761325 · Extracorporeal Medical Specialities, Inc. · Jan 1977