Cleared Traditional

K143449 - ADH 200 Analyzer Software

K143449 is an FDA 510(k) clearance for ADH 200 Analyzer Software, manufactured by Adams Meditech, LLC. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K143449 · Adams Meditech, LLC · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
206d
Days
Class 2
Risk

K143449 is an FDA 510(k) clearance for the ADH 200 Analyzer Software. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Adams Meditech, LLC (City Of Industry, US). The FDA issued a Cleared decision on June 26, 2015 after a review of 206 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 - K143449

510(k) Number K143449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date June 26, 2015
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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

Law Offices of Cecilia L. YU & Associates
CECILIA L. YU

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 - DQK Computer, Diagnostic, Programmable

All 414
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K143449.
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ECVUE MAPPING SYSTEM
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