Cleared Traditional

K921266 - NK MEDICAL MICROMETER, MODEL MC001

K921266 is an FDA 510(k) clearance for NK MEDICAL MICROMETER, manufactured by Nk Biotechnical Engineering Co.. The device is a Class 1 Orthopedic device with product code KTZ cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K921266 · Nk Biotechnical Engineering Co. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K921266

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.

KTZ Device Classification - Class 1, General Controls

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.