Cleared Traditional

K022540 - CARDIO ID+(RZ153+)

K022540 is the FDA 510(k) clearance for CARDIO ID+(RZ153+) by Rozinn Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K022540 · Rozinn Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2002
Decision
84d
Days
Class 2
Risk

K022540 is an FDA 510(k) clearance for the CARDIO ID+(RZ153+). Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Rozinn Electronics, Inc. (Glendale, US). The FDA issued a Cleared decision on October 24, 2002 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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 K022540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2002
Decision Date October 24, 2002
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSH Recorder, Magnetic Tape, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2800
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 - DSH Recorder, Magnetic Tape, Medical

All 74
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