Cleared Traditional

K842363 - PENLON ANESTHESIA VENTILATOR SERIES 300

K842363 is an FDA 510(k) clearance for PENLON ANESTHESIA VENTILATOR SERIES 300, manufactured by Bear Medical Systems, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K842363 · Bear Medical Systems, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1984
Decision
11d
Days
Class 2
Risk

K842363 is an FDA 510(k) clearance for the PENLON ANESTHESIA VENTILATOR SERIES 300. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Bear Medical Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 26, 1984 after a review of 11 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Bear Medical Systems, Inc. devices

FDA 510(k) Submission Details - K842363

510(k) Number K842363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1984
Decision Date June 26, 1984
Days to Decision 11 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
129d faster than avg
Panel avg: 140d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBK Device Classification - Class 2, Special Controls

Product Code CBK Ventilator, Continuous, Facility Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5895
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 - CBK Ventilator, Continuous, Facility Use

All 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K842363.
PORTABLE LIFECARE VENTILATOR PLV-102
K842876 · Lifecare Services, Inc. · Aug 1984
BEAR JET-150 VENTILATOR
K842688 · Bear Medical Systems, Inc. · Jul 1984
PENLON TRANSPORT VENTILATOR SERIES 350
K842362 · Bear Medical Systems, Inc. · Jun 1984
IMPULSE VENTILATOR
K841818 · Healthdyne, Inc. · Jun 1984
BEAR 33
K841279 · Bear Medical Systems, Inc. · May 1984
SIEMENS-ELEMA VENTILATOR 900C
K841529 · Siemens Elema AB · May 1984