510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023245Substantially Equivalent

Blood Flow Analyzer (Bfa), Model 408-100-01

Paradigm Medical Industries, Inc., Salt Lake City UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023245 is the FDA 510(k) clearance record for BLOOD FLOW ANALYZER (BFA), MODEL 408-100-01, a class II device, cleared for Paradigm Medical Industries, Inc. on under FDA product code NJJ (Tonometer, Analyzer, Ocular Blood Flow). FDA's definition for product code NJJ reads: "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...". FDA records list 10 510(k) clearances for Paradigm Medical Industries, Inc., from to . As of , FDA records show no recalls naming K023245.

Clearance record

Decision date
Received
(21 days to decision)
Product code
NJJ Tonometer, Analyzer, Ocular Blood Flow
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Paradigm Medical Industries, Inc. 2355 S. 1070 W., Salt Lake City UT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NJJ

Trailing 12 months

FDA records hold no clearances under product code NJJ in the trailing twelve months.

FDA records show no clearances under product code NJJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NJJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260