Cleared Traditional

K962687 - GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM

K962687 is an FDA 510(k) clearance for GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC..., manufactured by Nichols Institute Diagnostics. The device is a Class 1 Hematology device with product code JQW cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K962687 · Nichols Institute Diagnostics · Hematology device
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Mar 1997
Decision
260d
Days
Class 1
Risk

K962687 is an FDA 510(k) clearance for the GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Nichols Institute Diagnostics (San Juan Capistrano, US). The FDA issued a Cleared decision on March 28, 1997 after a review of 260 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.2750 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nichols Institute Diagnostics devices

FDA 510(k) Submission Details - K962687

510(k) Number K962687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1996
Decision Date March 28, 1997
Days to Decision 260 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 113d · This submission: 260d
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 K962687.
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IMPACT
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