Cleared Traditional

K840020 - FITNESS LOGGER

K840020 is an FDA 510(k) clearance for FITNESS LOGGER, manufactured by Britt Corp., Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 295-day FDA review.

K840020 · Britt Corp., Inc. · Cardiovascular device
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Oct 1984
Decision
295d
Days
Class 2
Risk

K840020 is an FDA 510(k) clearance for the FITNESS LOGGER. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Britt Corp., Inc. (Chanhassen, US). The FDA issued a Cleared decision on October 26, 1984 after a review of 295 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

View all Britt Corp., Inc. devices

FDA 510(k) Submission Details - K840020

510(k) Number K840020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received January 05, 1984
Decision Date October 26, 1984
Days to Decision 295 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 125d · This submission: 295d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 273
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K840020.
CARDIOSTAT 1 ECG RECORDER
K844392 · Siemens Elema AB · Apr 1985
MONITORING SYSTEM M720
K842944 · Burdick Corp. · Mar 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
ELECTROCARDIOGRAPH E-340
K840440 · Burdick Corp. · Aug 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
E 310 ELECTROCARDIOGRAPH
K833951 · Burdick Corp. · May 1984