Cleared Traditional

K933930 - PURITAN-BENNETT COMPANION 550 LIQUID OX...

K933930 is an FDA 510(k) clearance for PURITAN-BENNETT COMPANION 550 LIQUID OX..., 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 222-day FDA review.

K933930 · Puritan Bennett Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
222d
Days
Class 2
Risk

K933930 is an FDA 510(k) clearance for the PURITAN-BENNETT COMPANION 550 LIQUID OXYGEN PORTABLE UNIT. Classified as Unit, Liquid-oxygen, Portable (product code BYJ), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Lenexa, US). The FDA issued a Cleared decision on March 21, 1994 after a review of 222 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K933930

510(k) Number K933930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1993
Decision Date March 21, 1994
Days to Decision 222 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 140d · This submission: 222d
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 K933930.
PRECISION LIQUID OXYGEN SYSTEM
K041122 · Precision Medical, Inc. · Oct 2004
PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM
K993220 · Puritan Bennett Corp. · Oct 1999
LIQUID OXYGEN STORAGE SUBSYSTEM
K941819 · Hogan & Hartson · May 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
PURITAN-BENNETT COMPANION EMT LIQUID OXYGEN
K895387 · Puritan Bennett Corp. · Jan 1990