Cleared Traditional

HEMA(PRO)TEC(TION) (K885324) - FDA 510(k) Clearance

Class I Hematology device.

K885324 · Medical Products Search, Inc. · Hematology device
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Feb 1989
Decision
51d
Days
Class 1
Risk

K885324 is an FDA 510(k) clearance for the HEMA(PRO)TEC(TION). Classified as Tube, Collection, Capillary Blood (product code GIO), Class I - General Controls.

Submitted by Medical Products Search, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 17, 1989 after a review of 51 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 Medical Products Search, Inc. devices

Submission Details

510(k) Number K885324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1988
Decision Date February 17, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 113d · This submission: 51d
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.