Cleared Traditional

K860738 - CTC 30, 40, 1 LIQUID OXYGEN LITERS

K860738 is an FDA 510(k) clearance for CTC 30, manufactured by Cryodyne Technologies, Inc.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K860738 · Cryodyne Technologies, Inc. · Anesthesiology device
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Aug 1986
Decision
160d
Days
Class 2
Risk

K860738 is an FDA 510(k) clearance for the CTC 30, 40, 1 LIQUID OXYGEN LITERS. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Cryodyne Technologies, Inc. (Riviera Beach, US). The FDA issued a Cleared decision on August 6, 1986 after a review of 160 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5655 - 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 Cryodyne Technologies, Inc. devices

FDA 510(k) Submission Details - K860738

510(k) Number K860738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1986
Decision Date August 06, 1986
Days to Decision 160 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 140d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BYJ Device Classification - Class 2, Special Controls

Product Code BYJ Unit, Liquid-oxygen, Portable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5655
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BYJ Unit, Liquid-oxygen, Portable

All 30
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