Cleared Traditional

K820114 - SYSTEM V.HEART RATE/RESPIR. RATE MONIT.

K820114 is an FDA 510(k) clearance for SYSTEM V.HEART RATE/RESPIR. RATE MONIT., 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 28-day FDA review.

K820114 · Narco Air-Shields · Cardiovascular device
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Feb 1982
Decision
28d
Days
Class 2
Risk

K820114 is an FDA 510(k) clearance for the SYSTEM V.HEART RATE/RESPIR. RATE MONIT.. 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 February 12, 1982 after a review of 28 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 - K820114

510(k) Number K820114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1982
Decision Date February 12, 1982
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
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 K820114.
DIASCOPE 2
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#506 PORT. VITAL FUNCTIONS NEONATAL MON
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MODEL 2000 MONITOR
K812828 · Datascope Corp. · Nov 1981
INFANT CARIDAC MONITOR
K812674 · Electromed Intl., Ltd. · Oct 1981