Cleared Traditional

K922275 - UPSHERSCOPE(TM)

K922275 is the FDA 510(k) clearance for UPSHERSCOPE(TM) by Upsher Laryngoscope Co.. It is a Class 1 Anesthesiology device (product code CCW) cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K922275 · Upsher Laryngoscope Co. · Anesthesiology device
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Jan 1993
Decision
237d
Days
Class 1
Risk

K922275 is an FDA 510(k) clearance for the UPSHERSCOPE(TM). Classified as Laryngoscope, Rigid (product code CCW), Class I - General Controls.

Submitted by Upsher Laryngoscope Co. (Foster City, US). The FDA issued a Cleared decision on January 6, 1993 after a review of 237 days - an extended review cycle.

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 Upsher Laryngoscope Co. devices

Submission Details

510(k) Number K922275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1992
Decision Date January 06, 1993
Days to Decision 237 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 140d · This submission: 237d
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.

Regulatory Peers - CCW Laryngoscope, Rigid

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