Cleared Traditional

K862712 - EMERSON MODEL 3HV COMPACT VENTILATOR

K862712 is an FDA 510(k) clearance for EMERSON MODEL 3HV COMPACT VENTILATOR, manufactured by J. H. Emerson Co.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K862712 · J. H. Emerson Co. · Anesthesiology device
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Sep 1986
Decision
64d
Days
Class 2
Risk

K862712 is an FDA 510(k) clearance for the EMERSON MODEL 3HV COMPACT VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by J. H. Emerson Co. (Cambridge, US). The FDA issued a Cleared decision on September 18, 1986 after a review of 64 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 J. H. Emerson Co. devices

FDA 510(k) Submission Details - K862712

510(k) Number K862712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1986
Decision Date September 18, 1986
Days to Decision 64 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
76d faster than avg
Panel avg: 140d · This submission: 64d
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 K862712.
OHMEDA 7400 ANESTHESIA VENTILATOR
K864129 · Ohmeda Medical · Dec 1986
EMERSON 3MV VOLUME VENTILATOR
K864379 · J. H. Emerson Co. · Dec 1986
LUNG MECHANICS SOFTWARE PROGRAM
K864105 · Siemens Elema AB · Nov 1986
CPU GRAPH
K863546 · Ohmeda Medical · Sep 1986
COMPANION 2500 PORTABLE VOLUME VENTILATOR
K862810 · Puritan Bennett Corp. · Sep 1986
7200 MICROPROCESS VENT SYS/MODEL 7202 DISPLAY OPT
K862604 · Puritan Bennett Corp. · Aug 1986