Cleared Traditional

K833594 - FUKUDA DENSHI FX-302 AUTO/THREE CHAN

K833594 is an FDA 510(k) clearance for FUKUDA DENSHI FX-302 AUTO/THREE CHAN, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 335-day FDA review.

K833594 · Brentwood Instruments, Inc. · Cardiovascular device
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Sep 1984
Decision
335d
Days
Class 2
Risk

K833594 is an FDA 510(k) clearance for the FUKUDA DENSHI FX-302 AUTO/THREE CHAN. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Brentwood Instruments, Inc. devices

FDA 510(k) Submission Details - K833594

510(k) Number K833594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date September 11, 1984
Days to Decision 335 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
210d slower than avg
Panel avg: 125d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 202
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K833594.
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