Cleared Traditional

K823246 - AUSTIN INHALATOR

K823246 is an FDA 510(k) clearance for AUSTIN INHALATOR, manufactured by Ems Industries, Inc.. The device is a Class 1 Anesthesiology device with product code BYX cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K823246 · Ems Industries, Inc. · Anesthesiology device
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Dec 1982
Decision
45d
Days
Class 1
Risk

K823246 is an FDA 510(k) clearance for the AUSTIN INHALATOR. Classified as Tubing, Pressure And Accessories (product code BYX), Class I - General Controls.

Submitted by Ems Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1982 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5860 - 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.

View all Ems Industries, Inc. devices

FDA 510(k) Submission Details - K823246

510(k) Number K823246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1982
Decision Date December 16, 1982
Days to Decision 45 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 140d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

BYX Device Classification - Class 1, General Controls

Product Code BYX Tubing, Pressure And Accessories
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5860
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 - BYX Tubing, Pressure And Accessories

All 26
Devices cleared under the same product code (BYX) and FDA review panel - the closest regulatory comparables to K823246.
MEDIPART CORRUGATED POLYETHYLENE & E.V.A. TUBING
K853569 · Medipart Jerry Alexander · Nov 1985
OXYMIZER FLOW RESTRICTOR
K841901 · Chad Therapeutics, Inc. · Jul 1984
OXYGEN CONNECTING TUBE
K830988 · Medovations, Inc. · May 1983
OHIO AIR ADAPTOR
K813234 · Timeter Instrument Corp. · Dec 1981
TIMETER PRODUCED SCHRADER OXYGEN ADAPTOR
K811549 · Timeter Instrument Corp. · Jun 1981
TIMETER PRODUCED CHEMETRON (NCG) AIR
K811550 · Timeter Instrument Corp. · Jun 1981