Cleared Traditional

K831506 - DISP. TRANSDUCER W/MONITORING KIT TRANS

K831506 is an FDA 510(k) clearance for DISP. TRANSDUCER W/MONITORING KIT TRANS, 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 93-day FDA review.

K831506 · Sorensen Research · Cardiovascular device
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Aug 1983
Decision
93d
Days
Class 2
Risk

K831506 is an FDA 510(k) clearance for the DISP. TRANSDUCER W/MONITORING KIT TRANS. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Sorensen Research (Walker, US). The FDA issued a Cleared decision on August 12, 1983 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Sorensen Research devices

FDA 510(k) Submission Details - K831506

510(k) Number K831506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1983
Decision Date August 12, 1983
Days to Decision 93 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
32d faster than avg
Panel avg: 125d · This submission: 93d
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 K831506.
TRANSDUCER DOME SD104
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K833095 · Sorensen Research · Nov 1983
TRANSDUCER DOME DS106
K833096 · Sorensen Research · Nov 1983
DISPOSABLE PRESSURE TRANSDUCER#14004195
K831698 · Norton Performance Plastics Corp. · Aug 1983
DISPOSABLE PRESSURE TRANSDUCER
K830210 · American Pharmaseal Div. Ahsc · Apr 1983
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983