Cleared Traditional

K031182 - ELI 200+ AUDICOR

K031182 is the FDA 510(k) clearance for ELI 200+ AUDICOR by Mortara Instrument, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K031182 · Mortara Instrument, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
101d
Days
Class 2
Risk

K031182 is an FDA 510(k) clearance for the ELI 200+ AUDICOR. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on July 25, 2003 after a review of 101 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.

View all Mortara Instrument, Inc. devices

Submission Details

510(k) Number K031182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2003
Decision Date July 25, 2003
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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.
CHANTEL CARSON

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 220
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K031182.
12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
K050074 · Welch Allyn, Inc. · Mar 2005
CARDIOFAX CE, MODEL PEA-1110K
K042827 · Nihon Kohden America, Inc. · Jan 2005
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K042177 · Ge Medical Systems Information Technologies · Aug 2004
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291
K031422 · Philips Medical Systems · Jul 2003
PACEART SYSTEM
K024278 · Medtronic Vascular · May 2003
X-SCRIBE II
K022618 · Mortara Instrument, Inc. · Sep 2002