Cleared Traditional

K770946 - RECORD

K770946 is the FDA 510(k) clearance for RECORD by Instrumentation Laboratory CO. It is a Class 1 Cardiovascular device (product code DSF) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K770946 · Instrumentation Laboratory CO · Cardiovascular device
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Jul 1977
Decision
43d
Days
Class 1
Risk

K770946 is an FDA 510(k) clearance for the RECORD, MODEL 702, I.L.. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Instrumentation Laboratory CO (Mchenry, US). The FDA issued a Cleared decision on July 5, 1977 after a review of 43 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K770946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1977
Decision Date July 05, 1977
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 35
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K770946.
PHYSIOLOGICAL RECORDER MODEL 721A
K772052 · Datascope Corp. · Nov 1977
PHYSIOLOGICAL RECORDER MODEL 740
K772054 · Datascope Corp. · Nov 1977
SINGLE & DUAL CHANNEL RECORDER
K772048 · Hewlett-Packard Co. · Nov 1977
CALCULATOR PLOTTER (MODEL 9872A)
K761055 · Hewlett-Packard Co. · Dec 1976
LIFEPAK 5 CARDIOSCOPE-RECORDER MODULE
K760676 · Physio-Control Corp. · Oct 1976
RECORDER (#78640A)
K760539 · Hewlett-Packard Co. · Sep 1976