Cleared Traditional

K972096 - BIVALVE NASAL SPLINT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K972096 · Boston Medical Products, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
41d
Days
Class 1
Risk

K972096 is an FDA 510(k) clearance for the BIVALVE NASAL SPLINT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Boston Medical Products, Inc. (Westborough, US). The FDA issued a Cleared decision on July 15, 1997 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - the FDA ear, nose and throat 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: 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 Boston Medical Products, Inc. devices

Submission Details

510(k) Number K972096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1997
Decision Date July 15, 1997
Days to Decision 41 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 89d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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.