Cleared Traditional

SAFECRIT PLASTIC MICROHEMATOCRIT TUBES (K883185) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K883185 · Norfolk Scientific, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1988
Decision
21d
Days
Class 2
Risk

K883185 is an FDA 510(k) clearance for the SAFECRIT PLASTIC MICROHEMATOCRIT TUBES. Classified as Hematocrit, Tube, Rack, Sealer, Holder (product code GHY), Class II - Special Controls.

Submitted by Norfolk Scientific, Inc. (Norwood, US). The FDA issued a Cleared decision on August 18, 1988 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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 Norfolk Scientific, Inc. devices

Submission Details

510(k) Number K883185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1988
Decision Date August 18, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHY Hematocrit, Tube, Rack, Sealer, Holder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.