Cleared Traditional

K901385 - GABRIEL MEDICAL CLS THERMAL RECORDER

K901385 is an FDA 510(k) clearance for GABRIEL MEDICAL CLS THERMAL RECORDER, manufactured by Gabriel Medical, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K901385 · Gabriel Medical, Inc. · Cardiovascular device
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May 1990
Decision
44d
Days
Class 1
Risk

K901385 is an FDA 510(k) clearance for the GABRIEL MEDICAL CLS THERMAL RECORDER. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Gabriel Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 9, 1990 after a review of 44 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 Gabriel Medical, Inc. devices

FDA 510(k) Submission Details - K901385

510(k) Number K901385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1990
Decision Date May 09, 1990
Days to Decision 44 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 125d · This submission: 44d
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 51
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K901385.
MODEL 556 MONITOR
K905856 · Ge Medical Systems Information Technologies · Jan 1991
COLORADO COLOR IMAGING RECORDER
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CARDIOCAP(TM) DR-104 REPORTER
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FOUR-CHANNEL/EIGHT-CHANNEL THERMAL ARRAY RECORDER
K884897 · Mennen Medical, Inc. · Mar 1989
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K881831 · Nihon Kohden America, Inc. · Jul 1988