Cleared Traditional

K810893 - HEWLETT-PACKARD VENTILATOR

K810893 is the FDA 510(k) clearance for HEWLETT-PACKARD VENTILATOR by Hewlett-Packard Co.. It is a Class 2 Anesthesiology device (product code CBK) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K810893 · Hewlett-Packard Co. · Anesthesiology device
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Jun 1981
Decision
77d
Days
Class 2
Risk

K810893 is an FDA 510(k) clearance for the HEWLETT-PACKARD VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on June 18, 1981 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5895 - 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K810893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1981
Decision Date June 18, 1981
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. No clinical trials required.

Device Classification

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 222
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K810893.
JET VENTILATOR
K813254 · Healthdyne, Inc. · Feb 1982
BABYBIRD 2 VENTILATOR
K820132 · 3M Company · Jan 1982
ENGSTROM ERICA
K812642 · Lkb Instruments, Inc. · Nov 1981
SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
K811102 · Siemens Elema AB · May 1981
DRAGER AV2 ANESTHESIA VENTILATOR
K802168 · Draeger Medical, Inc. · Dec 1980
INFANT VENTILATOR, (RESPIRATOR) PLAN B
K802583 · Healthdyne, Inc. · Dec 1980