510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913809Substantially Equivalent

Hy-Prep System

Hyperion, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913809 is the FDA 510(k) clearance record for HY-PREP SYSTEM, a class I device, cleared for Hyperion, Inc. on under FDA product code JQW (Station, Pipetting And Diluting, For Clinical Use). FDA records list 8 510(k) clearances for Hyperion, Inc., from to . As of , FDA records show no recalls naming K913809.

Clearance record

Decision date
Received
(142 days to decision)
Product code
JQW Station, Pipetting And Diluting, For Clinical Use
Regulation
21 CFR 862.2750
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Hyperion, Inc. 14100 SW 136th St., Miami FL
510(k) summary
Statement
Third party review
No

Clearances, product code JQW

Trailing 12 months

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

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