Cleared Traditional

K831481 - DIXIE USA PTL

K831481 is the FDA 510(k) clearance for DIXIE USA PTL by Eugene Scarberry. It is a Class 2 Cardiovascular device (product code DSK) cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K831481 · Eugene Scarberry · Cardiovascular device
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Oct 1983
Decision
148d
Days
Class 2
Risk

K831481 is an FDA 510(k) clearance for the DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Eugene Scarberry (Walker, US). The FDA issued a Cleared decision on October 4, 1983 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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 Eugene Scarberry devices

Submission Details

510(k) Number K831481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1983
Decision Date October 04, 1983
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 125d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 34
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K831481.
SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULE
K860689 · Spacelabs, Inc. · Jul 1986
HORIZON 2000 PHYSIOLOGICAL PATIENT MONITOR
K850879 · Mennen Medical, Inc. · Apr 1985
LME BLOOD PRESSURE MONITOR
K832017 · Litton Medical Electronics · Oct 1983
MODEL 78553A PRESSURE PLUG-IN MODULE
K822878 · Hewlett-Packard Co. · Oct 1982
MODEL 1100 SPHYGMOMANOMETER
K811208 · Y · May 1981
PERIPHERAL PULSE FUNCTION BLOCKS
K810171 · Honeywell, Inc. · Feb 1981