Cleared Traditional

K792117 - AIR-SHIELDS HEART RATE MONITOR

K792117 is an FDA 510(k) clearance for AIR-SHIELDS HEART RATE MONITOR, manufactured by Narco Air-Shields. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K792117 · Narco Air-Shields · Cardiovascular device
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Nov 1979
Decision
18d
Days
Class 2
Risk

K792117 is an FDA 510(k) clearance for the AIR-SHIELDS HEART RATE MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Narco Air-Shields (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: 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 - K792117

510(k) Number K792117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1979
Decision Date November 13, 1979
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.

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 196
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K792117.
PDS COMPUTER UNIT/VIDEO TERMINAL
K801761 · General Electric Co. · Aug 1980
A-V MINI CLINIC
K800405 · Instromedix, Inc. · Jul 1980
HEART RATE MONITOR MD-1
K792312 · Medical Devices, Inc. · Nov 1979
AS7 & AS8 MONITORS
K790552 · Narco Air-Shields · May 1979
MODEL 78801A PATIENT MONITORS
K790454 · Hewlett-Packard Co. · Apr 1979
MONITOR, ELECTROCARDIOSCOPE
K790292 · Burdick Corp. · Feb 1979