Cleared Traditional

K091358 - ECSCOPE 100

K091358 is an FDA 510(k) clearance for ECSCOPE 100, 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 20-day FDA review.

K091358 · Dyansys, Inc. · Cardiovascular device
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May 2009
Decision
20d
Days
Class 2
Risk

K091358 is an FDA 510(k) clearance for the ECSCOPE 100. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Dyansys, Inc. (Burlingame, US). The FDA issued a Cleared decision on May 28, 2009 after a review of 20 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 - K091358

510(k) Number K091358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2009
Decision Date May 28, 2009
Days to Decision 20 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
105d faster than avg
Panel avg: 125d · This submission: 20d
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 DIVINE

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 K091358.
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
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · Edan Instruments, Inc. · Jun 2009
MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM
K090249 · Harbinger Medical, Inc. · Apr 2009
MORTARA STRESS ECHO BED
K082967 · Medical Positioning, Inc. · Mar 2009
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
K090483 · Philips Medical Systems · Mar 2009