Cleared Traditional

K822305 - ORTHO-LEVEL (FDA 510(k) Clearance)

Class I Orthopedic device.

K822305 · Frontier Products · Orthopedic device
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Aug 1982
Decision
24d
Days
Class 1
Risk

K822305 is an FDA 510(k) clearance for the ORTHO-LEVEL. Classified as Protractor (product code HTH), Class I - General Controls.

Submitted by Frontier Products (Mchenry, US). The FDA issued a Cleared decision on August 20, 1982 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4600 - 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: 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 Frontier Products devices

Submission Details

510(k) Number K822305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1982
Decision Date August 20, 1982
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HTH Protractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4600
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.