Cleared Traditional

K800141 - ACCUSTROKE PIPET

K800141 is an FDA 510(k) clearance for ACCUSTROKE PIPET, manufactured by Beckman Instruments, Inc.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K800141 · Beckman Instruments, Inc. · Chemistry device
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Feb 1980
Decision
23d
Days
Class 1
Risk

K800141 is an FDA 510(k) clearance for the ACCUSTROKE PIPET. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 13, 1980 after a review of 23 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.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K800141

510(k) Number K800141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1980
Decision Date February 13, 1980
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 83
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K800141.
RIAUSE AUTO PROCESSOR
K801030 · Electro-Nucleonics Laboratories, Inc. · May 1980
MICROMEDIC AUTOMATIC DILUTER
K800606 · Micromedic Systems · Apr 1980
MICROMEDIC PUNCH & ELUTER
K800075 · Micromedic Systems · Feb 1980
MICROMEDIC APS2
K791324 · Micromedic Systems · Aug 1979
ACCESSORY KIT, CENTRIFICHEM
K790041 · Union Carbide Corp. · Feb 1979
MINI-DILUTER 2
K782130 · Dynatech Laboratories, Inc. · Feb 1979