Cleared Traditional

K802800 - NARCO AIR-SHEILDS SYS. 100 MONITOR SYS

K802800 is an FDA 510(k) clearance for NARCO AIR-SHEILDS SYS. 100 MONITOR SYS, manufactured by Narco Air-Shields. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K802800 · Narco Air-Shields · Cardiovascular device
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Nov 1980
Decision
18d
Days
Class 2
Risk

K802800 is an FDA 510(k) clearance for the NARCO AIR-SHEILDS SYS. 100 MONITOR SYS. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Narco Air-Shields (Mchenry, US). The FDA issued a Cleared decision on November 24, 1980 after a review of 18 days - a notably fast clearance cycle.

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: 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 Narco Air-Shields devices

FDA 510(k) Submission Details - K802800

510(k) Number K802800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1980
Decision Date November 24, 1980
Days to Decision 18 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
107d faster than avg
Panel avg: 125d · This submission: 18d
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 91
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K802800.
TREND GRAPH FUNCTION BLOCK
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K802476 · Gould, Inc. · Nov 1980
MLC-4200 CARDIAC OUTPUT COMPUTER
K802305 · Nihon Kohden America, Inc. · Oct 1980
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K792678 · Nihon Kohden America, Inc. · Jan 1980