Cleared Traditional

K021517 - ABP FOR WINDOWS

K021517 is an FDA 510(k) clearance for ABP FOR WINDOWS, manufactured by Rozinn Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DSK cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K021517 · Rozinn Electronics, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
75d
Days
Class 2
Risk

K021517 is an FDA 510(k) clearance for the ABP FOR WINDOWS. Classified as Computer, Blood-pressure (product code DSK), Class II - Special Controls.

Submitted by Rozinn Electronics, Inc. (Glendale, US). The FDA issued a Cleared decision on July 24, 2002 after a review of 75 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1110 - 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.

FDA 510(k) Submission Details - K021517

510(k) Number K021517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2002
Decision Date July 24, 2002
Days to Decision 75 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
50d faster than avg
Panel avg: 125d · This submission: 75d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSK Device Classification - Class 2, Special Controls

Product Code DSK Computer, Blood-pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1110
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 - DSK Computer, Blood-pressure

All 76
Devices cleared under the same product code (DSK) and FDA review panel - the closest regulatory comparables to K021517.
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K021517 · ABP FOR WINDOWS
Download PDF FDA Summary Rozinn Electronics, I…