Cleared Traditional

K833096 - TRANSDUCER DOME DS106

K833096 is the FDA 510(k) clearance for TRANSDUCER DOME DS106 by Sorensen Research. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K833096 · Sorensen Research · Cardiovascular device
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Nov 1983
Decision
52d
Days
Class 2
Risk

K833096 is an FDA 510(k) clearance for the TRANSDUCER DOME DS106. 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 November 3, 1983 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 K833096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1983
Decision Date November 03, 1983
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 K833096.
DISPOSABLE MANIFOLD SET
K832657 · Mallinckrodt Critical Care · Nov 1983
TRANSDUCER DOME SD104
K833094 · Sorensen Research · Nov 1983
TRANSDUCER DOME SD105
K833095 · Sorensen Research · Nov 1983
DISP. TRANSDUCER W/MONITORING KIT TRANS
K831506 · Sorensen Research · Aug 1983
USCI ELECTRONIC MANOMETER
K830093 · C.R. Bard, Inc. · Jan 1983
FLEX-E1 ECG ELECTRODE
K820579 · Conmedcorp · Apr 1982