Cleared Traditional

K861488 - COMPANION 2800 VOLUME VENTILATOR REMOTE...

K861488 is an FDA 510(k) clearance for COMPANION 2800 VOLUME VENTILATOR REMOTE..., manufactured by Puritan Bennett Corp.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K861488 · Puritan Bennett Corp. · Anesthesiology device
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May 1986
Decision
27d
Days
Class 2
Risk

K861488 is an FDA 510(k) clearance for the COMPANION 2800 VOLUME VENTILATOR REMOTE ALARM. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Puritan Bennett Corp. (Overland Park, US). The FDA issued a Cleared decision on May 6, 1986 after a review of 27 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 Puritan Bennett Corp. devices

FDA 510(k) Submission Details - K861488

510(k) Number K861488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1986
Decision Date May 06, 1986
Days to Decision 27 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
113d faster than avg
Panel avg: 140d · This submission: 27d
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 249
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K861488.
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K862604 · Puritan Bennett Corp. · Aug 1986
MASTER PROGRAM FLOW & PRESSURE CO2 & LUNG MONITOR
K861707 · Siemens Elema AB · Jun 1986
ENGSTROM ERICA II RESPIRATOR
K862025 · Gambro, Inc. · Jun 1986
COMPANION 2800 VOLUME VENTILATOR REMOT ALARM
K860675 · Puritan Bennett Corp. · Apr 1986
HONEYWELL ELECTRONIC VENTILATOR EV-A
K853501 · Honeywell, Inc. · Apr 1986
MODIFICATION 7200 MICROPROCESSOR VENTILATOR SYSTEM
K854070 · Puritan Bennett Corp. · Feb 1986