Cleared Traditional

K791636 - ACCUNAMIC

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

K791636 · Sorensen Research · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K791636

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.

DRS Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K791636.
MEDI-TRACE TRANSDUCERS/PHYSIOLOG. MONITO
K800705 · Graphic Controls Corp. · Apr 1980
MEDI-TRACE DISPOSABLE DOMES/MONITORING
K800706 · Graphic Controls Corp. · Apr 1980
MODEL 1979 BLOOD PRESSUROMETER R CHARTER
K792073 · Del Mar Avionics · Nov 1979
MICROTEC BACTERIAL FILTER
K790407 · Medex, Inc. · May 1979
MONITORING, PRESSURE KIT
K781680 · Pharmaseal Div., Baxter Healthcare Corp. · Oct 1978
TRANSDUCER, PRESSURE, OPTION, H-P, P23ID
K780797 · Gould, Inc. · Jun 1978