Cleared Traditional

ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR (K852018) - FDA 510(k) Clearance

K852018 · Manan Manufacturing Co., Inc. · General & Plastic Surgery device
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Jul 1985
Decision
64d
Days
-
Risk

K852018 is an FDA 510(k) clearance for the ARTHROGRAM TRAY FOR DOUBLE & SINGLE CONTRAST ARTHR.

Submitted by Manan Manufacturing Co., Inc. (Skokie, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Manan Manufacturing Co., Inc. devices

Submission Details

510(k) Number K852018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received May 08, 1985
Decision Date July 11, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -