Cleared Traditional

HAEMOFUGE A. BIOFUGE A. & B (K840767) - FDA 510(k) Clearance

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

K840767 · Heraeus-Christ GmbH · Hematology device
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Apr 1984
Decision
54d
Days
Class 2
Risk

K840767 is an FDA 510(k) clearance for the HAEMOFUGE A. BIOFUGE A. & B. Classified as Device, Hematocrit Measuring (product code JPI), Class II - Special Controls.

Submitted by Heraeus-Christ GmbH (Walker, US). The FDA issued a Cleared decision on April 17, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - 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 Heraeus-Christ GmbH devices

Submission Details

510(k) Number K840767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1984
Decision Date April 17, 1984
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. No clinical trials required.

Device Classification

Product Code JPI Device, Hematocrit Measuring
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.