Cleared Traditional

K042463 - HOLTER PLUS

K042463 is the FDA 510(k) clearance for HOLTER PLUS by Rozinn Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K042463 · Rozinn Electronics, Inc. · Cardiovascular device
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Sep 2004
Decision
9d
Days
Class 2
Risk

K042463 is an FDA 510(k) clearance for the HOLTER PLUS. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Rozinn Electronics, Inc. (Glendale, US). The FDA issued a Cleared decision on September 22, 2004 after a review of 9 days - a notably fast clearance 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: 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 Rozinn Electronics, Inc. devices

Submission Details

510(k) Number K042463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date September 22, 2004
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Peers - DQK Computer, Diagnostic, Programmable

All 247
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