Cleared Traditional

K792081 - SPECTRA CENTRAL PT MONITORING SYS

K792081 is the FDA 510(k) clearance for SPECTRA CENTRAL PT MONITORING SYS by American Optical Corp.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K792081 · American Optical Corp. · Cardiovascular device
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Nov 1979
Decision
28d
Days
Class 2
Risk

K792081 is an FDA 510(k) clearance for the SPECTRA CENTRAL PT MONITORING SYS. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by American Optical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 American Optical Corp. devices

Submission Details

510(k) Number K792081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1979
Decision Date November 13, 1979
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.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 220
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K792081.
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · General Electric Co. · Sep 1980
EVALUATOR #9500 DYNAMIC ELEC/SCANNER
K801831 · Del Mar Avionics · Sep 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · General Electric Co. · Aug 1980
DCG-VII ELECTROCARDIOSCANNER
K791424 · Del Mar Avionics · Aug 1979
MODEL 78520A ARRHYTHMIA MONITORING SYS
K791487 · Hewlett-Packard Co. · Aug 1979
ARRHYTHMIA II CARDULE
K790837 · Spacelabs, Inc. · May 1979