Cleared Traditional

K910140 - ELECTRAPETTE (R)

K910140 is an FDA 510(k) clearance for ELECTRAPETTE, manufactured by Matrix Technologies Corp.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K910140 · Matrix Technologies Corp. · Chemistry device
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Feb 1991
Decision
21d
Days
Class 1
Risk

K910140 is an FDA 510(k) clearance for the ELECTRAPETTE (R). Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Matrix Technologies Corp. (Lowell, US). The FDA issued a Cleared decision on February 4, 1991 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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.

FDA 510(k) Submission Details - K910140

510(k) Number K910140 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1991
Decision Date February 04, 1991
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 89d · This submission: 21d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K910140.
ROBOTIC SAMPLE PROCESSOR
K912036 · Tecan U.S., Ltd. · Jul 1991
MARK 5 ROBOTIC PIPETTOR
K912228 · Diagnostic Products Corp. · Jun 1991
STRATUS(R) AUTOMATED SAMPLE HANDLER
K911712 · Baxter Healthcare Corp · May 1991
EPC ELECTRONIC PIPETTING SYSTEM
K902592 · Ulster Scientific, Inc. · Jul 1990
MICROPLATE REAGENT DISPENSER
K900599 · Denley Instruments, Inc. · May 1990
KEMBLE LIQUID HANDLING SYSTEM DISPENSER
K896684 · Schiff & Co. · Apr 1990
K910140 · ELECTRAPETTE (R)
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