Cleared Traditional

K961832 - BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K961832 · Blue Ridge Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
116d
Days
Class 1
Risk

K961832 is an FDA 510(k) clearance for the BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Blue Ridge Medical, Inc. (Gray, US). The FDA issued a Cleared decision on September 6, 1996 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5540 - the FDA anesthesiology and respiratory 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Blue Ridge Medical, Inc. devices

Submission Details

510(k) Number K961832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1996
Decision Date September 06, 1996
Days to Decision 116 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 139d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCW Laryngoscope, Rigid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5540
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.