Cleared Traditional

K831506 - DISP. TRANSDUCER W/MONITORING KIT TRANS

K831506 is the FDA 510(k) clearance for DISP. TRANSDUCER W/MONITORING KIT TRANS by Sorensen Research. It is a Class 2 Cardiovascular device (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

Submission Details

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.

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 K831506.
TRANSDUCER DOME SD104
K833094 · Sorensen Research · Nov 1983
TRANSDUCER DOME SD105
K833095 · Sorensen Research · Nov 1983
TRANSDUCER DOME DS106
K833096 · Sorensen Research · Nov 1983
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
FLEX-E1 ECG ELECTRODE
K820579 · Conmedcorp · Apr 1982
BARD CARDIOPULMONARY MONITORING LINES
K820186 · C.R. Bard, Inc. · Feb 1982