Cleared Traditional

K813426 - MULTIWASH

K813426 is an FDA 510(k) clearance for MULTIWASH, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K813426 · Flow Laboratories, Inc. · Chemistry device
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Dec 1981
Decision
15d
Days
Class 1
Risk

K813426 is an FDA 510(k) clearance for the MULTIWASH. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1981 after a review of 15 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 - K813426

510(k) Number K813426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1981
Decision Date December 22, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 89d · This submission: 15d
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 K813426.
ECLIPSE
K821007 · Scientific Software & Instrument Co. · May 1982
SKATRON REPEATING DISPENSER
K821034 · Skatron, Inc. · May 1982
UNI-PUMP 200
K821039 · Scientific Mfg. Industries, Inc. · May 1982
DSD
K812983 · Pm America, Inc. · Nov 1981
DISPENSER ASPIRATOR DA 300
K812782 · Pharmacia, Inc. · Oct 1981
EMIT AUTO CAROUSEL
K812647 · Syva Co. · Oct 1981
K813426 · MULTIWASH
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