Cleared Traditional

K921266 - NK MEDICAL MICROMETER, MODEL MC001 (FDA 510(k) Clearance)

Class I Orthopedic device.

K921266 · Nk Biotechnical Engineering Co. · Orthopedic device
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Jul 1992
Decision
120d
Days
Class 1
Risk

K921266 is an FDA 510(k) clearance for the NK MEDICAL MICROMETER, MODEL MC001. Classified as Caliper (product code KTZ), Class I - General Controls.

Submitted by Nk Biotechnical Engineering Co. (Minneapolis, US). The FDA issued a Cleared decision on July 14, 1992 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4150 - the FDA orthopedic device regulatory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Nk Biotechnical Engineering Co. devices

Submission Details

510(k) Number K921266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1992
Decision Date July 14, 1992
Days to Decision 120 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 122d · This submission: 120d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KTZ Caliper
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4150
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.