Cleared Traditional

K860848 - VITAL FLOW NASAL CPAP SYSTEM

K860848 is an FDA 510(k) clearance for VITAL FLOW NASAL CPAP SYSTEM, manufactured by Systems 2000, Inc.. The device is a Class 2 Anesthesiology device with 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.

FDA 510(k) Submission Details - K860848

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.

BYE Device Classification - Class 2, Special Controls

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 70
Devices cleared under the same product code (BYE) and FDA review panel - the closest regulatory comparables to K860848.
SLEEP APNEA NASAL CPAP SYSTEM
K871693 · Puritan Bennett Corp. · Sep 1987
RESPIRONICS SANDERS BIPAPEASY
K871523 · Respironics, Inc. · Jul 1987
CUSHION-FLEX TM NASAL CPAP MASK FOR SLEEP APNEA
K861758 · Life Design Systems, Inc. · Jul 1986
LDS PEEP VALVE
K854822 · Life Design Systems, Inc. · Feb 1986
CUSHION-FLEX TM-CPAP FACE MASK
K854458 · Life Design Systems, Inc. · Jan 1986
SANDER'S MASKCPAP BY RESPIRONICS
K851396 · Respironics, Inc. · May 1985
K860848 · VITAL FLOW NASAL CPAP SYSTEM
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