510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053257Substantially Equivalent

Para-Pro Fc50

Alpha-Tec Systems, Inc., Vancouver WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K053257 is the FDA 510(k) clearance record for PARA-PRO FC50, a class I device, cleared for Alpha-Tec Systems, Inc. on under FDA product code LKS (Device, Parasite Concentration). FDA records list 18 510(k) clearances for Alpha-Tec Systems, Inc., from to . As of , FDA records show no recalls naming K053257.

Clearance record

Decision date
Received
(171 days to decision)
Product code
LKS Device, Parasite Concentration
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Alpha-Tec Systems, Inc. 12019 NE 99th St., #1780, Vancouver WA
510(k) summary
Statement
Third party review
No

Clearances, product code LKS

Trailing 12 months

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

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