Cleared Traditional

K860848 - VITAL FLOW NASAL CPAP SYSTEM

K860848 is the FDA 510(k) clearance for VITAL FLOW NASAL CPAP SYSTEM by Systems 2000, Inc.. It is a Class 2 Anesthesiology device (product code BYE) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K860848 · Systems 2000, Inc. · Anesthesiology device
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Jun 1986
Decision
98d
Days
Class 2
Risk

K860848 is an FDA 510(k) clearance for the VITAL FLOW NASAL CPAP SYSTEM. Classified as Attachment, Breathing, Positive End Expiratory Pressure (product code BYE), Class II - Special Controls.

Submitted by Systems 2000, Inc. (Riverside, US). The FDA issued a Cleared decision on June 12, 1986 after a review of 98 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Systems 2000, Inc. devices

Submission Details

510(k) Number K860848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1986
Decision Date June 12, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 140d · This submission: 98d
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 22
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K860848.
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