Cleared Traditional

K861104 - VARIABLE HIGH FLOW DOWNS CPAP GENERATOR

K861104 is the FDA 510(k) clearance for VARIABLE HIGH FLOW DOWNS CPAP GENERATOR by Med Air Technology, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K861104 · Med Air Technology, Inc. · Anesthesiology device
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Apr 1986
Decision
35d
Days
Class 2
Risk

K861104 is an FDA 510(k) clearance for the VARIABLE HIGH FLOW DOWNS CPAP GENERATOR. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Med Air Technology, Inc. (Springfield, US). The FDA issued a Cleared decision on April 28, 1986 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5965 - 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 Med Air Technology, Inc. devices

Submission Details

510(k) Number K861104 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1986
Decision Date April 28, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BYE Attachment, Breathing, Positive End Expiratory Pressure
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5965
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 - BYE Attachment, Breathing, Positive End Expiratory Pressure

All 21
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K861104.
MODIFIED OHMEDA PEEP VALVE (FOR GMS ABSORBER)
K881614 · Ohmeda Medical · Apr 1988
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · Puritan Bennett Corp. · Sep 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · Respironics, Inc. · Jul 1987
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · Respironics, Inc. · May 1985
RESPIRONICS SLEEPEASY NASAL CPAP SYS
K843889 · Respironics, Inc. · Dec 1984
OHMEDA PEEP VALVE FOR GMS ABSORBER
K843835 · Ohmeda Medical · Nov 1984