Cleared Traditional

K893714 - KEYSTONE OXYGEN TENT

K893714 is an FDA 510(k) clearance for KEYSTONE OXYGEN TENT, manufactured by Keystone Veterinary Supplies, Inc.. The device is a Class 1 Anesthesiology device with product code BYL cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K893714 · Keystone Veterinary Supplies, Inc. · Anesthesiology device
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Aug 1989
Decision
95d
Days
Class 1
Risk

K893714 is an FDA 510(k) clearance for the KEYSTONE OXYGEN TENT. Classified as Tent, Oxygen (product code BYL), Class I - General Controls.

Submitted by Keystone Veterinary Supplies, Inc. (Blackwood, US). The FDA issued a Cleared decision on August 21, 1989 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5700 - 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 Keystone Veterinary Supplies, Inc. devices

FDA 510(k) Submission Details - K893714

510(k) Number K893714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1989
Decision Date August 21, 1989
Days to Decision 95 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 140d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

BYL Device Classification - Class 1, General Controls

Product Code BYL Tent, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5700
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.