Cleared Traditional

CAPILLARY TUBE, BLOOD COLLECTION (K885138) - FDA 510(k) Clearance

Class I Hematology device.

K885138 · Coeur Laboratories, Inc. · Hematology device
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Feb 1989
Decision
54d
Days
Class 1
Risk

K885138 is an FDA 510(k) clearance for the CAPILLARY TUBE, BLOOD COLLECTION. Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Coeur Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6150 - 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: 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 Coeur Laboratories, Inc. devices

Submission Details

510(k) Number K885138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1988
Decision Date February 07, 1989
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 113d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIO Tube, Collection, Capillary Blood
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.6150
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.