Cleared Abbreviated

K110065 - SPAULDING IQ ELECTROCARDIOGRAPH

K110065 is an FDA 510(k) clearance for SPAULDING IQ ELECTROCARDIOGRAPH, manufactured by Spaulding Clinical Research, LLC. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Abbreviated 510(k) pathway after a 51-day FDA review.

K110065 · Spaulding Clinical Research, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
51d
Days
Class 2
Risk

K110065 is an FDA 510(k) clearance for the SPAULDING IQ ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Spaulding Clinical Research, LLC (West Bend, US). The FDA issued a Cleared decision on March 2, 2011 after a review of 51 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Spaulding Clinical Research, LLC devices

FDA 510(k) Submission Details - K110065

510(k) Number K110065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2011
Decision Date March 02, 2011
Days to Decision 51 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
Pathway characteristics
Standards-based clearance path.

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 306
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K110065.
ACG-8511 PORTABLE ECG MONITOR
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MAC 600 RESTING ECG ANALYSIS SYSTEM
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MAC 5500 HD, MAC 3500
K110266 · Ge Medical Systems Information Technologies, Inc. · Apr 2011
V-TRUST MODEL TD-2202 PORTABLE ECG RECORDER
K101569 · Taidoc Technology Corporation · Mar 2011
ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
K102206 · Mortara Instrument, Inc. · Feb 2011
PC ECG
K102854 · Edan Instruments, Inc. · Dec 2010