Cleared Traditional

K801831 - EVALUATOR #9500 DYNAMIC ELEC/SCANNER

K801831 is the FDA 510(k) clearance for EVALUATOR #9500 DYNAMIC ELEC/SCANNER by Del Mar Avionics. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K801831 · Del Mar Avionics · Cardiovascular device
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Sep 1980
Decision
39d
Days
Class 2
Risk

K801831 is an FDA 510(k) clearance for the EVALUATOR #9500 DYNAMIC ELEC/SCANNER. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Del Mar Avionics (Mchenry, US). The FDA issued a Cleared decision on September 9, 1980 after a review of 39 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 Del Mar Avionics devices

Submission Details

510(k) Number K801831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1980
Decision Date September 09, 1980
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 225
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K801831.
GUARDIAN MONITOR (CARDIOVASCULAR)
K803282 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
OXFORD INTENSIVE CARE PATIENT MON. SYS
K802033 · Oxford Medilog, Inc. · Sep 1980
ECG RECALL & EDIT PRODUCT VERSION-A3601
K802103 · General Electric Co. · Sep 1980
MICRO-PROCESSOR UNIT #A3600AC
K801762 · General Electric Co. · Aug 1980
SPECTRA CENTRAL PT MONITORING SYS
K792081 · American Optical Corp. · Nov 1979
DCG-VII ELECTROCARDIOSCANNER
K791424 · Del Mar Avionics · Aug 1979