Cleared Traditional

K791971 - MONOJECT SICKLE CELL KIT (FDA 510(k) Clearance)

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

K791971 · Sherwood Medical Co. · Immunology device
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Nov 1979
Decision
34d
Days
Class 2
Risk

K791971 is an FDA 510(k) clearance for the MONOJECT SICKLE CELL KIT. Classified as Test, Sickle Cell (product code GHM), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Walker, US). The FDA issued a Cleared decision on November 5, 1979 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 864.7825 - the FDA immunology 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K791971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1979
Decision Date November 05, 1979
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 104d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GHM Test, Sickle Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7825
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 Immunology devices follow this clearance model.