Cleared Traditional

K922902 - SALMAN SINUS BUTTON (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K922902 · Boston Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
336d
Days
Class 1
Risk

K922902 is an FDA 510(k) clearance for the SALMAN SINUS BUTTON. Classified as Cannula, Sinus (product code KAM), Class I - General Controls.

Submitted by Boston Medical Products, Inc. (Waltham, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 336 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Medical Products, Inc. devices

Submission Details

510(k) Number K922902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1992
Decision Date May 18, 1993
Days to Decision 336 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
222d slower than avg
Panel avg: 114d · This submission: 336d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KAM Cannula, Sinus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.