Cleared Traditional

K961832 - BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER

K961832 is an FDA 510(k) clearance for BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE ..., manufactured by Blue Ridge Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CCW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K961832 · Blue Ridge Medical, Inc. · Anesthesiology device
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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

FDA 510(k) Submission Details - K961832

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 140d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

CCW Device Classification - Class 1, General Controls

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.

Regulatory Peers - CCW Laryngoscope, Rigid

All 20
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