Cleared Traditional

K844101 - CARDIO-NEC MODEL 365

K844101 is an FDA 510(k) clearance for CARDIO-NEC MODEL 365, manufactured by Birtcher Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K844101 · Birtcher Corp. · Cardiovascular device
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Apr 1985
Decision
168d
Days
Class 2
Risk

K844101 is an FDA 510(k) clearance for the CARDIO-NEC MODEL 365. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Birtcher Corp. (El Monte, US). The FDA issued a Cleared decision on April 9, 1985 after a review of 168 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 Birtcher Corp. devices

FDA 510(k) Submission Details - K844101

510(k) Number K844101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date April 09, 1985
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K844101.
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985
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