Cleared Traditional

K831481 - DIXIE USA PTL, PHARYNGEAL TRACHEAL LUMEN

K831481 is an FDA 510(k) clearance for DIXIE USA PTL, manufactured by Eugene Scarberry. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K831481

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.

DSK Device Classification - Class 2, Special Controls

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 54
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