Cleared Traditional

K091397 - ECSCOPE 200

K091397 is an FDA 510(k) clearance for ECSCOPE 200, manufactured by Dyansys, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K091397 · Dyansys, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
57d
Days
Class 2
Risk

K091397 is an FDA 510(k) clearance for the ECSCOPE 200. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dyansys, Inc. (Burlingame, US). The FDA issued a Cleared decision on July 8, 2009 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dyansys, Inc. devices

FDA 510(k) Submission Details - K091397

510(k) Number K091397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2009
Decision Date July 08, 2009
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DPS Electrocardiograph

All 466
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K091397.
GEM HEART ONE/ONE+
K092576 · Gem-Med S.L. · Sep 2009
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
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · Edan Instruments, Inc. · Jun 2009
ECSCOPE 100
K091358 · Dyansys, Inc. · May 2009
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
K090249 · Harbinger Medical, Inc. · Apr 2009