Cleared Special

K102830 - ELECTROCARDIOGRAPH

K102830 is an FDA 510(k) clearance for ELECTROCARDIOGRAPH, manufactured by Edan Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Special 510(k) pathway after a 64-day FDA review.

K102830 · Edan Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
64d
Days
Class 2
Risk

K102830 is an FDA 510(k) clearance for the ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on December 2, 2010 after a review of 64 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K102830

510(k) Number K102830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2010
Decision Date December 02, 2010
Days to Decision 64 days
Submission Type Special
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
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 538
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K102830.
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
K102206 · Mortara Instrument, Inc. · Feb 2011
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K101016 · Caird Technology · Jan 2011
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K102854 · Edan Instruments, Inc. · Dec 2010
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K100813 · Pulse Biomedical, Inc. · Jul 2010
ELI 250 ELECTROCARDIOGRAPH
K101403 · Mortara Instrument, Inc. · Jul 2010
ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
K101115 · Mortara Instrument, Inc. · Jun 2010
K102830 · ELECTROCARDIOGRAPH
Download PDF FDA Summary Edan Instruments, Inc.