Cleared Traditional

K923397 - SINGLE DOSE GAS INJECTOR

K923397 is an FDA 510(k) clearance for SINGLE DOSE GAS INJECTOR, manufactured by Escalon Medical Trek. The device is a Class 1 Anesthesiology device with product code BXX cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K923397 · Escalon Medical Trek · Anesthesiology device
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Sep 1992
Decision
66d
Days
Class 1
Risk

K923397 is an FDA 510(k) clearance for the SINGLE DOSE GAS INJECTOR. Classified as Calibrator, Pressure, Gas (product code BXX), Class I - General Controls.

Submitted by Escalon Medical Trek (Mukwonago, US). The FDA issued a Cleared decision on September 14, 1992 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K923397

510(k) Number K923397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1992
Decision Date September 14, 1992
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

BXX Device Classification - Class 1, General Controls

Product Code BXX Calibrator, Pressure, Gas
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2620
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 - BXX Calibrator, Pressure, Gas

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