Cleared Traditional

K080884 - QHRV 1 - HEALTH ASSESSMENT SYSTEM

K080884 is an FDA 510(k) clearance for QHRV 1 - HEALTH ASSESSMENT SYSTEM, manufactured by Medtechs, LLC. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K080884 · Medtechs, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
11d
Days
Class 2
Risk

K080884 is an FDA 510(k) clearance for the QHRV 1 - HEALTH ASSESSMENT SYSTEM. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Medtechs, LLC (Durhan, US). The FDA issued a Cleared decision on April 11, 2008 after a review of 11 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtechs, LLC devices

FDA 510(k) Submission Details - K080884

510(k) Number K080884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2008
Decision Date April 11, 2008
Days to Decision 11 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
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Regulatory Technology Services, LLC
MARK JOB

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 471
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