Cleared Traditional

K812904 - STERILE ORTHOPEDIC STOCKINETTE

K812904 is an FDA 510(k) clearance for STERILE ORTHOPEDIC STOCKINETTE, manufactured by Alba Health Care. The device is a Class 1 Orthopedic device with product code LGF cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K812904 · Alba Health Care · Orthopedic device
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Jan 1982
Decision
91d
Days
Class 1
Risk

K812904 is an FDA 510(k) clearance for the STERILE ORTHOPEDIC STOCKINETTE. Classified as Component, Cast (product code LGF), Class I - General Controls.

Submitted by Alba Health Care (Mchenry, US). The FDA issued a Cleared decision on January 18, 1982 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.5940 - 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 Alba Health Care devices

FDA 510(k) Submission Details - K812904

510(k) Number K812904 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1981
Decision Date January 18, 1982
Days to Decision 91 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 122d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LGF Device Classification - Class 1, General Controls

Product Code LGF Component, Cast
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.5940
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.