Cleared Traditional

HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI KIT-PN 4207 (K974854) - FDA 510(k) Clearance

Class I Chemistry device.

K974854 · Morax · Chemistry device
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Optimized for regulatory review, auditing and printing
Oct 1998
Decision
282d
Days
Class 1
Risk

K974854 is an FDA 510(k) clearance for the HYDRAGEL-MINI LIPO KIT-PN 4093, HYDRAGEL LIPO KIT-PN 4007, HYDRAGEL LIPO MAXI.... Classified as Electrophoretic Separation, Lipoproteins (product code JHO), Class I - General Controls.

Submitted by Morax (Chelsea, US). The FDA issued a Cleared decision on October 7, 1998 after a review of 282 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Morax devices

Submission Details

510(k) Number K974854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1997
Decision Date October 07, 1998
Days to Decision 282 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
194d slower than avg
Panel avg: 88d · This submission: 282d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JHO Electrophoretic Separation, Lipoproteins
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JHO Electrophoretic Separation, Lipoproteins

All 25
Devices cleared under the same product code (JHO) and FDA review panel - the closest regulatory comparables to K974854.
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · Helena Laboratories · Aug 2002
SPIFE 2000/3000 LIPOPROTEIN
K013466 · Helena Laboratories · Dec 2001
SPIFE CHOLESTEROL PROFILE KIT
K000603 · Helena Laboratories · Apr 2000
REP CHOLESTEROL PROFILE KIT
K992971 · Helena Laboratories · Oct 1999
REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8
K980650 · Helena Laboratories · May 1998
REP 3 QUTO-FLUR CHOLESTEROL-30
K962914 · Helena Laboratories · Jan 1997