Cleared Traditional

K801145 - SMI MULTI-TUBE VORTEXER

K801145 is an FDA 510(k) clearance for SMI MULTI-TUBE VORTEXER, manufactured by Scientific Manufacturing Industries. The device is a Class 1 Chemistry device with product code JRQ cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K801145 · Scientific Manufacturing Industries · Chemistry device
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Jun 1980
Decision
27d
Days
Class 1
Risk

K801145 is an FDA 510(k) clearance for the SMI MULTI-TUBE VORTEXER. Classified as Shaker/stirrer (product code JRQ), Class I - General Controls.

Submitted by Scientific Manufacturing Industries (Walker, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2050 - 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 Scientific Manufacturing Industries devices

FDA 510(k) Submission Details - K801145

510(k) Number K801145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1980
Decision Date June 09, 1980
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

JRQ Device Classification - Class 1, General Controls

Product Code JRQ Shaker/stirrer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2050
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 - JRQ Shaker/stirrer

Devices cleared under the same product code (JRQ) and FDA review panel - the closest regulatory comparables to K801145.
MINI-SHAKER
K813318 · Dynatech Corp. · Dec 1981
S/P VORTEX MIXER
K813148 · American Dade · Nov 1981
S/P VORTEX MIXER JR.
K813149 · American Dade · Nov 1981
DIMENSIONALL ROTATOR
K790753 · American Hospital Supply Corp. · Jun 1979
SHAKER, MODEL SH-510
K790027 · Sysmex Corp. · Feb 1979
MICRO-MIX PIPETTE SHAKER
K770165 · Maddak, Inc. · Jan 1977