Cleared Traditional

K903331 - ROZINN 151

K903331 is the FDA 510(k) clearance for ROZINN 151 by Rozinn Electronics, Inc.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K903331 · Rozinn Electronics, Inc. · Cardiovascular device
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Oct 1990
Decision
89d
Days
Class 2
Risk

K903331 is an FDA 510(k) clearance for the ROZINN 151. 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 22, 1990 after a review of 89 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 K903331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date October 22, 1990
Days to Decision 89 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 125d · This submission: 89d
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
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K903331.
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PR4
K911097 · Mortara Instrument, Inc. · Aug 1991
MICROPOTENTIAL ANALYZER/SPECTROCARDIOGRAPHY OPTION
K895793 · Del Mar Avionics · Feb 1990
MEDILOG 9000-II AMBULATORY RECORDER
K890647 · Oxford Medilog, Inc. · Mar 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · Del Mar Avionics · Jan 1989