510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K974854Substantially Equivalent

Hydragel-Mini Lipo Kit-Pn 4093, Hydragel Lipo Kit-Pn 4007, Hydragel Lipo Maxi Kit-Pn 4207

Morax, Chelsea MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K974854 is the FDA 510(k) clearance record for HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207, a class I device, cleared for Morax on under FDA product code JHO (Electrophoretic Separation, Lipoproteins). FDA records list 11 510(k) clearances for Morax, from to . As of , FDA records show no recalls naming K974854.

Clearance record

Decision date
Received
(282 days to decision)
Product code
JHO Electrophoretic Separation, Lipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Morax 13805 Waterloo Rd., Chelsea MI
510(k) summary
Summary
Third party review
No

Clearances, product code JHO

Trailing 12 months

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

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