Cleared Traditional

K831430 - AIR SHIELDS AS-100 MONIORING SYS-AS105

K831430 is an FDA 510(k) clearance for AIR SHIELDS AS-100 MONIORING SYS-AS105, manufactured by Narco Scientific. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K831430 · Narco Scientific · Cardiovascular device
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Sep 1983
Decision
132d
Days
Class 2
Risk

K831430 is an FDA 510(k) clearance for the AIR SHIELDS AS-100 MONIORING SYS-AS105. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Narco Scientific (Mchenry, US). The FDA issued a Cleared decision on September 12, 1983 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Narco Scientific devices

FDA 510(k) Submission Details - K831430

510(k) Number K831430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1983
Decision Date September 12, 1983
Days to Decision 132 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
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 202
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K831430.
PATIENT MONITOR #78832A
K831944 · Hewlett-Packard Co. · Oct 1983
AS 1740 INTERFACE MODULE
K831428 · Narco Scientific · Oct 1983
PATIENT MONITOR #78353A
K831787 · Hewlett-Packard Co. · Sep 1983
PHYSIOLOGICAL MONITOR #902
K831578 · Novametrix Medical Systems, Inc. · Aug 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885 · Gould, Inc. · Jun 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517 · Marquette Electronics, Inc. · Jun 1983