Cleared Traditional

K771903 - LIPASE

K771903 is an FDA 510(k) clearance for LIPASE, manufactured by Simmler & Son, Inc.. The device is a Class 1 Chemistry device with product code CDT cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K771903 · Simmler & Son, Inc. · Chemistry device
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Dec 1977
Decision
60d
Days
Class 1
Risk

K771903 is an FDA 510(k) clearance for the LIPASE. Classified as Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (product code CDT), Class I - General Controls.

Submitted by Simmler & Son, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 6, 1977 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1705 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Simmler & Son, Inc. devices

FDA 510(k) Submission Details - K771903

510(k) Number K771903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1977
Decision Date December 06, 1977
Days to Decision 60 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 88d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

CDT Device Classification - Class 1, General Controls

Product Code CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1705
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 - CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 136
Devices cleared under the same product code (CDT) and FDA review panel - the closest regulatory comparables to K771903.
ENZYMATIC TRIGLYCERIDES REAGENT KIT
K781240 · J.T. Baker Chemical Co. · Aug 1978
DATA-ZYME TRIGLYCERIDE PROCEDURE
K780379 · Data Medical Associates, Inc. · May 1978
TRIGLYCERIDE INSTRUMENT APPLICATION
K780172 · Harleco · Mar 1978
A-GENT TRIGLYCERIDES
K771608 · Abbott Laboratories · Sep 1977
AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI
K771004 · Miles Laboratories, Inc. · Sep 1977
TRIGLYCERIDE REAGENT SET
K770993 · Macomb Chemical Co. · Sep 1977