Cleared Traditional

K895387 - PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN

K895387 is an FDA 510(k) clearance for PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN, manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code BYJ cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K895387 · Puritan Bennett Corp. · Anesthesiology device
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Jan 1990
Decision
147d
Days
Class 2
Risk

K895387 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on January 24, 1990 after a review of 147 days - within the typical 510(k) review window.

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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K895387

510(k) Number K895387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date January 24, 1990
Days to Decision 147 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 140d · This submission: 147d
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 18
Devices cleared under the same product code (BYJ) and FDA review panel - the closest regulatory comparables to K895387.
PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT
K933930 · Puritan Bennett Corp. · Mar 1994
MOBILAIRE LIQUID OXYGEN SYSTEMS
K926267 · Invacare Corp. · Aug 1993
PURITAN-BENNETT COMPAN EMT W/REMOTE LIQ LEV GUAGE
K903140 · Puritan Bennett Corp. · Sep 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