Cleared Traditional

K852487 - FUKUDA DENSHI MODEL AU-5001-5003 THERMAL

K852487 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL AU-5001-5003 THERMAL, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 1 Cardiovascular device with product code DSF cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K852487 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Sep 1985
Decision
100d
Days
Class 1
Risk

K852487 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL AU-5001-5003 THERMAL. Classified as Recorder, Paper Chart (product code DSF), Class I - General Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on September 19, 1985 after a review of 100 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K852487

510(k) Number K852487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date September 19, 1985
Days to Decision 100 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
25d faster than avg
Panel avg: 125d · This submission: 100d
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 86
Devices cleared under the same product code (DSF) and FDA review panel - the closest regulatory comparables to K852487.
MODEL 535 NEO-TRAK RECORDER
K855045 · Ge Medical Systems Information Technologies · May 1986
LONG TERM RECORDER RAG 1200
K854866 · Nihon Kohden America, Inc. · Apr 1986
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000
K851625 · Eaton Medical Group · Nov 1985
SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
K851626 · Eaton Medical Group · Jun 1985
OHMEDA MODEL 0001/0003 RECORDER
K851274 · Ohmeda Medical · May 1985
RECORDING ACCESSORY FOR G-2000 EKG MACH. GMP-40 RE
K850365 · Eaton Medical Group · Apr 1985
K852487 · FUKUDA DENSHI MODEL AU-5001-5003 THERMAL
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