Cleared Traditional

K922275 - UPSHERSCOPE(TM)

K922275 is an FDA 510(k) clearance for UPSHERSCOPE(TM), manufactured by Upsher Laryngoscope Co.. The device is a Class 1 Anesthesiology device with 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

FDA 510(k) Submission Details - K922275

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.

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 32
Devices cleared under the same product code (CCW) and FDA review panel - the closest regulatory comparables to K922275.
THE WUSCOPE SYSTEM
K941319 · Achi Corp. · Oct 1994
FILLISCOPE
K930804 · Filliscope, Inc. · Oct 1993
SLATER SLEEVE
K926158 · Tadco, Inc. · Mar 1993
AUGUSTINE FIBEROPTIC LARYNGOSCOPE
K915161 · Augustine Medical, Inc. · May 1992
AUGUSTINE GUIDE KIT
K921166 · Augustine Medical, Inc. · Apr 1992
BAUMAN DISPOSABLE LARYNGOSCOPE BLADES
K905273 · Vital Signs, Inc. · Mar 1992