Cleared Traditional

K822109 - SHOVEL RETRACTOR (FDA 510(k) Clearance)

Class I Orthopedic device.

K822109 · Bio-Blitz, Inc. · Orthopedic device
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Jul 1982
Decision
11d
Days
Class 1
Risk

K822109 is an FDA 510(k) clearance for the SHOVEL RETRACTOR. Classified as Accessories, Arthroscopic (product code NBH), Class I - General Controls.

Submitted by Bio-Blitz, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 30, 1982 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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 Bio-Blitz, Inc. devices

Submission Details

510(k) Number K822109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1982
Decision Date July 30, 1982
Days to Decision 11 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 122d · This submission: 11d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NBH Accessories, Arthroscopic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.1100
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.