Cleared Traditional

K830399 - COUPLING/VALVE

K830399 is an FDA 510(k) clearance for COUPLING/VALVE, manufactured by Khi, Inc.. The device is a Class 1 Anesthesiology device with product code BTC cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K830399 · Khi, Inc. · Anesthesiology device
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Mar 1983
Decision
31d
Days
Class 1
Risk

K830399 is an FDA 510(k) clearance for the COUPLING/VALVE. Classified as Bag, Reservoir (product code BTC), Class I - General Controls.

Submitted by Khi, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 10, 1983 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5320 - 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 - K830399

510(k) Number K830399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1983
Decision Date March 10, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
109d faster than avg
Panel avg: 140d · This submission: 31d
Pathway characteristics
Predicate-based equivalence.

BTC Device Classification - Class 1, General Controls

Product Code BTC Bag, Reservoir
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5320
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 - BTC Bag, Reservoir

All 12
Devices cleared under the same product code (BTC) and FDA review panel - the closest regulatory comparables to K830399.
BREATHING BAGS
K932191 · Life Shield Healthcare Products, Inc. · Jul 1993
ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER
K894906 · Med-Tek Corp. · Sep 1989
KING SYSTEMS, BREATHING BAG
K880680 · King Systems Corp. · Mar 1988
ANESTHESIA BREATHING BAG, VARIOUS SIZES
K822116 · Life Design Systems, Inc. · Aug 1982
VOLUMETRIC CONTROLLER
K822216 · Quest Medical, Inc. · Aug 1982
DISPOSAL LITER BREATHING BAG
K800155 · Dryden Corp. · Feb 1980
K830399 · COUPLING/VALVE
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