Cleared Traditional

K860738 - CTC 30

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

K860738 · Cryodyne Technologies, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 16
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K860738.
MOBILAIRE LIQUID OXYGEN SYSTEMS
K926267 · Invacare Corp. · Aug 1993
PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE
K903140 · Puritan Bennett Corp. · Sep 1990
PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN
K895387 · Puritan Bennett Corp. · Jan 1990
COMPANION LIQUID OXYGEN SYSTEM
K861503 · Puritan Bennett Corp. · Jun 1986
MARK 4 LIQUID OXYGEN SYSTEM
K860937 · Puritan Bennett Corp. · Mar 1986
MARK III OXYGEN WALKER SYS-LOW PRESS
K830337 · Union Carbide Corp. · Mar 1983