Cleared Traditional

K092010 - PC ECG, MODEL SE-1010

K092010 is an FDA 510(k) clearance for PC ECG, 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 108-day FDA review.

K092010 · Edan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
108d
Days
Class 2
Risk

K092010 is an FDA 510(k) clearance for the PC ECG, MODEL SE-1010. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Yonkers, US). The FDA issued a Cleared decision on October 22, 2009 after a review of 108 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 - K092010

510(k) Number K092010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date October 22, 2009
Days to Decision 108 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
17d faster than avg
Panel avg: 125d · This submission: 108d
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 K092010.
ELI PC ELECTROCARDIOGRAPH
K093339 · Mortara Instrument, Inc. · Feb 2010
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
K093172 · Dynacardia, Inc. · Jan 2010
ELI 350 ELECTROCARDIOGRAPH
K092663 · Mortara Instrument, Inc. · Dec 2009
BELTBEAT WF-400
K083715 · Bonus Communicaciones Srl · Sep 2009
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
K092010 · PC ECG, MODEL SE-1010
Download PDF FDA Summary Edan Instruments, Inc.