Cleared Traditional

K893660 - ECG SIMULATOR MODEL ECGPLUS

K893660 is the FDA 510(k) clearance for ECG SIMULATOR MODEL ECGPLUS by Bio-Tek Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K893660 · Bio-Tek Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1989
Decision
204d
Days
Class 2
Risk

K893660 is an FDA 510(k) clearance for the ECG SIMULATOR MODEL ECGPLUS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Bio-Tek Instruments, Inc. (Winooski, US). The FDA issued a Cleared decision on December 5, 1989 after a review of 204 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 Bio-Tek Instruments, Inc. devices

Submission Details

510(k) Number K893660 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1989
Decision Date December 05, 1989
Days to Decision 204 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
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 265
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K893660.
NKA MODELS AB-601G AND AB-621G
K900272 · Nihon Kohden America, Inc. · Jan 1990
MINIMON 7133B PATIENT MONITOR
K896386 · Kontron Instruments, Inc. · Dec 1989
KONTRON KOLORMON 7250 PATIENT MONITOR
K896417 · Kontron Instruments, Inc. · Dec 1989
E350 ELECTROCARDIOGRAPH
K892835 · Burdick Corp. · Jun 1989
TYPE 9040 SYSTEM ATHENA
K884116 · S & W Medico Teknik · Apr 1989
7610 COLORVIEW SLAVE SCOPE
K890481 · Marquette Electronics, Inc. · Mar 1989