510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820533Substantially Equivalent

B4182-1

American Scientific Products, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820533 is the FDA 510(k) clearance record for B4182-1, a class II device, cleared for American Scientific Products on under FDA product code GIE (Fibrometer). FDA records list 28 510(k) clearances for American Scientific Products, from to . As of , FDA records show no recalls naming K820533.

Clearance record

Decision date
Received
(37 days to decision)
Product code
GIE Fibrometer
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
American Scientific Products 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GIE

Trailing 12 months

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

FDA records show no clearances under product code GIE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GIE, 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