Cleared Traditional

K896152 - PURITAN-BENNETT OXYGEN PRESSURE REGULAT...

K896152 is an FDA 510(k) clearance for PURITAN-BENNETT OXYGEN PRESSURE REGULAT..., manufactured by Puritan Bennett Corp.. The device is a Class 1 Anesthesiology device with product code CAN cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K896152 · Puritan Bennett Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
77d
Days
Class 1
Risk

K896152 is an FDA 510(k) clearance for the PURITAN-BENNETT OXYGEN PRESSURE REGULATOR W/FLOW.. Classified as Regulator, Pressure, Gas Cylinder (product code CAN), Class I - General Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on January 9, 1990 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2700 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K896152

510(k) Number K896152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1989
Decision Date January 09, 1990
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

CAN Device Classification - Class 1, General Controls

Product Code CAN Regulator, Pressure, Gas Cylinder
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.2700
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.

Regulatory Peers - CAN Regulator, Pressure, Gas Cylinder

All 12
Devices cleared under the same product code (CAN) and FDA review panel - the closest regulatory comparables to K896152.
SALTER LABS DISPOSABLE NIPPLE AND NUT
K912174 · Salter Labs · Jul 1991
PRECISION MEDICAL OXYGEN REGULATOR
K901831 · Precision Medical, Inc. · Aug 1990
PURITAN-BENNETT OXYGEN PRESSURE REGULATOR
K896128 · Puritan Bennett Corp. · Jan 1990
BE #1100 MOISTURE TRAP & BE #1102/50 DISP CANISTER
K884927 · Instrumentation Industries, Inc. · Jun 1989
DOWNS VPAP CIRCUIT
K852333 · Vital Signs, Inc. · Oct 1985
PRESSURE REGULATOR/Y CONNECTOR
K852649 · C.R. Bard, Inc. · Aug 1985