Cleared Traditional

NASAL SEPTAL BUTTON (K850492) - FDA 510(k) Clearance

K850492 · Santa Barbara Medco, Inc. · Ear, Nose, Throat device
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Mar 1985
Decision
27d
Days
-
Risk

K850492 is an FDA 510(k) clearance for the NASAL SEPTAL BUTTON. Classified as Button, Nasal Septal (product code LFB).

Submitted by Santa Barbara Medco, Inc. (Santa Barbara, US). The FDA issued a Cleared decision on March 7, 1985 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat 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 Santa Barbara Medco, Inc. devices

Submission Details

510(k) Number K850492 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1985
Decision Date March 07, 1985
Days to Decision 27 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 89d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LFB Button, Nasal Septal
Device Class -