Cleared Traditional

K884911 - CORTRONIC SCR1000

K884911 is an FDA 510(k) clearance for CORTRONIC SCR1000, manufactured by Cortronic Corp.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K884911 · Cortronic Corp. · Cardiovascular device
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Jan 1989
Decision
49d
Days
Class 1
Risk

K884911 is an FDA 510(k) clearance for the CORTRONIC SCR1000. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Cortronic Corp. (Ronkonkoma, US). The FDA issued a Cleared decision on January 13, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2810 - 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 Cortronic Corp. devices

FDA 510(k) Submission Details - K884911

510(k) Number K884911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1988
Decision Date January 13, 1989
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

DSF Device Classification - Class 1, General Controls

Product Code DSF Recorder, Paper Chart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.2810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DSF Recorder, Paper Chart

All 57
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K884911.
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K883315 · Edentec Corp. · Dec 1988
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K881831 · Nihon Kohden America, Inc. · Jul 1988