Cleared Traditional

K896670 - TIP TOP(R) DISPENSER CAPS

K896670 is an FDA 510(k) clearance for TIP TOP DISPENSER CAPS, manufactured by Helena Laboratories. The device is a Class 1 Hematology device with product code GJW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K896670 · Helena Laboratories · Hematology device
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Mar 1990
Decision
116d
Days
Class 1
Risk

K896670 is an FDA 510(k) clearance for the TIP TOP(R) DISPENSER CAPS. Classified as Pipette, Pasteur (product code GJW), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6160 - 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 Helena Laboratories devices

FDA 510(k) Submission Details - K896670

510(k) Number K896670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1989
Decision Date March 23, 1990
Days to Decision 116 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 113d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

GJW Device Classification - Class 1, General Controls

Product Code GJW Pipette, Pasteur
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6160
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.