Cleared Traditional

K850800 - DROPSTIRS - PLASTIC DISPOSABLE PIPET

K850800 is the FDA 510(k) clearance for DROPSTIRS - PLASTIC DISPOSABLE PIPET by Berwick Medical Products, Inc.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K850800 · Berwick Medical Products, Inc. · Chemistry device
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Apr 1985
Decision
34d
Days
Class 1
Risk

K850800 is an FDA 510(k) clearance for the DROPSTIRS - PLASTIC DISPOSABLE PIPET. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Berwick Medical Products, Inc. (Warminster, US). The FDA issued a Cleared decision on April 2, 1985 after a review of 34 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 Berwick Medical Products, Inc. devices

Submission Details

510(k) Number K850800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1985
Decision Date April 02, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 64
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K850800.
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