Cleared Traditional

K905273 - BAUMAN DISPOSABLE LARYNGOSCOPE BLADES (FDA 510(k) Clearance)

Class I Anesthesiology device.

K905273 · Vital Signs, Inc. · Anesthesiology device
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Mar 1992
Decision
487d
Days
Class 1
Risk

K905273 is an FDA 510(k) clearance for the BAUMAN DISPOSABLE LARYNGOSCOPE BLADES. Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Vital Signs, Inc. (Totowa, US). The FDA issued a Cleared decision on March 24, 1992 after a review of 487 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

View all Vital Signs, Inc. devices

Submission Details

510(k) Number K905273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1990
Decision Date March 24, 1992
Days to Decision 487 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
348d slower than avg
Panel avg: 139d · This submission: 487d
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.