Cleared Traditional

K850845 - 0.85% SALINE

K850845 is an FDA 510(k) clearance for 0.85% SALINE, manufactured by Micro Media Laboratories. The device is a Class 1 Pathology device with product code PPM cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K850845 · Micro Media Laboratories · Pathology device
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Mar 1985
Decision
19d
Days
Class 1
Risk

K850845 is an FDA 510(k) clearance for the 0.85% SALINE. Classified as General Purpose Reagent (product code PPM), Class I - General Controls.

Submitted by Micro Media Laboratories (San Diego, US). The FDA issued a Cleared decision on March 20, 1985 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.4010 - the FDA pathology device 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 Micro Media Laboratories devices

FDA 510(k) Submission Details - K850845

510(k) Number K850845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date March 20, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 77d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

PPM Device Classification - Class 1, General Controls

Product Code PPM General Purpose Reagent
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
Definition A General Purpose Reagent Is A Chemical Reagent That Has General Laboratory Application, That Is Used To Collect, Prepare, And Examine Specimens From The Human Body For Diagnostic Purposes, And That Is Not Labeled Or Otherwise Intended For A Specific Diagnostic Application. It May Be Either An Individual Substance, Or Multiple Substances Reformulated, Which, When Combined With Or Used In Conjunction With An Appropriate Analyte Specific Reagent (asr) And Other General Purpose Reagents, Is Part Of A Diagnostic Test Procedure Or System Constituting A Finished In Vitro Diagnostic (ivd) Test.
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 - PPM General Purpose Reagent

All 9
Devices cleared under the same product code (PPM) and FDA review panel - the closest regulatory comparables to K850845.
POTASSIUM HYDROXIDE 10% W/V
K863550 · Reagent Laboratory, Inc. · Oct 1986
100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2
K861890 · Richard-Allan Medical Ind., Inc. · Jun 1986
SPRAYFIX
K850916 · Surgipath Medical Industries, Inc. · Mar 1985
DECOLORIZING FLUIC, ACID-ALCOHOL 3%
K842934 · E K Ind., Inc. · Sep 1984
DECOLORIZING FLUID
K842729 · E K Ind., Inc. · Aug 1984
VOLU-SOL TAP WATER SUBSTITUTE
K822037 · Volu Sol Medical Industries · Aug 1982