Cleared Traditional

K842706 - SCATAID

K842706 is an FDA 510(k) clearance for SCATAID, manufactured by Sc Applied Technology, Inc.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K842706 · Sc Applied Technology, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
138d
Days
Class 2
Risk

K842706 is an FDA 510(k) clearance for the SCATAID. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Sc Applied Technology, Inc. (Washington, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Sc Applied Technology, Inc. devices

FDA 510(k) Submission Details - K842706

510(k) Number K842706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1984
Decision Date November 27, 1984
Days to Decision 138 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 117
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K842706.
CARDIAC COMPUTER SP1445
K843555 · Gould, Inc. · Feb 1985
RIGHT VENTRICULAR EJECTION FRACTION-
K842105 · American Edwards Laboratories · Jan 1985
SAT-1 OXIMETER/CARDIAC OUTPUT COMPUTER
K841401 · American Edwards Laboratories · Jan 1985
RECOMED CARDIAC OUTPUT METER 236067-
K840439 · Litton Medical Electronics · Nov 1984
ELECATH VENTRICULAR PACING THERMAL DILUTION CATH
K844022 · Electro-Catheter Corp. · Nov 1984
MODELS 78551A 78552A
K841256 · Hewlett-Packard Co. · Oct 1984