Cleared Traditional

K090367 - SE-601 SERIES ELECTROCARDIOGRAPH

K090367 is an FDA 510(k) clearance for SE-601 SERIES ELECTROCARDIOGRAPH, manufactured by Edan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K090367 · Edan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2009
Decision
110d
Days
Class 2
Risk

K090367 is an FDA 510(k) clearance for the SE-601 SERIES ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on June 3, 2009 after a review of 110 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K090367

510(k) Number K090367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2009
Decision Date June 03, 2009
Days to Decision 110 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 125d · This submission: 110d
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 577
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K090367.
SINGLE-CHANNEL HANDHELD ELECTROCARDIOGRAPH, MODEL ECG80A
K090936 · Contec Medical System Co., Ltd. · Aug 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
K091513 · Edan Instruments, Inc. · Jul 2009
ECSCOPE 200
K091397 · Dyansys, Inc. · Jul 2009
ECSCOPE 100
K091358 · Dyansys, Inc. · May 2009
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
K090249 · Harbinger Medical, Inc. · Apr 2009
MORTARA STRESS ECHO BED
K082967 · Medical Positioning, Inc. · Mar 2009
K090367 · SE-601 SERIES ELECTROCARDIOGRAPH
Download PDF FDA Summary Edan Instruments, Inc.