Cleared Traditional

K023245 - BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01 (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K023245 · Paradigm Medical Industries, Inc. · Ophthalmic device
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Oct 2002
Decision
21d
Days
Class 2
Risk

K023245 is an FDA 510(k) clearance for the BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01. Classified as Tonometer, Analyzer, Ocular Blood Flow (product code NJJ), Class II - Special Controls.

Submitted by Paradigm Medical Industries, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 21, 2002 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device 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 Paradigm Medical Industries, Inc. devices

Submission Details

510(k) Number K023245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2002
Decision Date October 21, 2002
Days to Decision 21 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 110d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJJ Tonometer, Analyzer, Ocular Blood Flow
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
Definition Tonometry For Measuring And Recording Intraocular Pressures And Intraocular Pulse Amplitudes, Pulsatile Ocular Blood Flow, Pulsatile Ocular Blood Volume, Pulsatility Index Equivalent. Description Of Why Current Product C Lassificaiton Name/product Code Will Not Suffice: This Device Measures Intraocular Pressure, Which Is What A Tonometer Does. However, Because It Can Measure The Small Changes In Pressure Caused By The Blood Pressure Pulse In The Ocular Arterial Vessels, It Is Also Capable Of Measuring And Calculating Parameters Associated With The Ocular Blood Flow, Including Intraocular Pressure Pulse Amplitude, Pulsatile Ocular Blood Flow, And Pulsatile Ocular Blood Volume.
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 Ophthalmic devices follow this clearance model.