Cleared Traditional

K863308 - 2200I PHYSIOLOGICAL MONITOR

K863308 is an FDA 510(k) clearance for 2200I PHYSIOLOGICAL MONITOR, manufactured by Datascope Corp.. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K863308 · Datascope Corp. · Cardiovascular device
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Jan 1987
Decision
130d
Days
Class 2
Risk

K863308 is an FDA 510(k) clearance for the 2200I PHYSIOLOGICAL MONITOR. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Datascope Corp. (Paramus, US). The FDA issued a Cleared decision on January 2, 1987 after a review of 130 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 Datascope Corp. devices

FDA 510(k) Submission Details - K863308

510(k) Number K863308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date January 02, 1987
Days to Decision 130 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
5d slower than avg
Panel avg: 125d · This submission: 130d
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 104
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K863308.
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ARRHYTHMIA REVIEW STATION
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