Cleared Traditional

K922870 - THREE SPIKE CUP

K922870 is an FDA 510(k) clearance for THREE SPIKE CUP, manufactured by Osteo Technology, Inc.. The device is a Class 1 Microbiology device with product code GRF cleared through the Traditional 510(k) pathway after a 308-day FDA review.

K922870 · Osteo Technology, Inc. · Microbiology device
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Apr 1993
Decision
308d
Days
Class 1
Risk

K922870 is an FDA 510(k) clearance for the THREE SPIKE CUP. Classified as Antiserum, Cf, Rubeola (product code GRF), Class I - General Controls.

Submitted by Osteo Technology, Inc. (Timonium, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 308 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3520 - the FDA microbiology 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteo Technology, Inc. devices

FDA 510(k) Submission Details - K922870

510(k) Number K922870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1992
Decision Date April 08, 1993
Days to Decision 308 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 102d · This submission: 308d
Pathway characteristics
Predicate-based equivalence.

GRF Device Classification - Class 1, General Controls

Product Code GRF Antiserum, Cf, Rubeola
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
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.