Cleared Traditional

K082351 - NEPTUNE HYPERBARIC VENTILATOR

K082351 is an FDA 510(k) clearance for NEPTUNE HYPERBARIC VENTILATOR, manufactured by Level-5, Inc.. The device is a Class 2 Anesthesiology device with product code CBK cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K082351 · Level-5, Inc. · Anesthesiology device
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Jan 2009
Decision
140d
Days
Class 2
Risk

K082351 is an FDA 510(k) clearance for the NEPTUNE HYPERBARIC VENTILATOR. Classified as Ventilator, Continuous, Facility Use (product code CBK), Class II - Special Controls.

Submitted by Level-5, Inc. (Washington, US). The FDA issued a Cleared decision on January 2, 2009 after a review of 140 days - within the typical 510(k) review window.

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: 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 Level-5, Inc. devices

FDA 510(k) Submission Details - K082351

510(k) Number K082351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2008
Decision Date January 02, 2009
Days to Decision 140 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 140d · This submission: 140d
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 327
Devices cleared under the same product code (CBK) and FDA review panel - the closest regulatory comparables to K082351.
HAMILTON-C2
K090468 · Hamilton Medical AG · Jun 2009
TRILOGY 100 VENTILATOR
K083526 · Respironics Inc., Sleep & Home Respiratory Group · Mar 2009
HOSPITAL FULL FACE MASK NON VENTED, MODEL: RT041
K083122 · Fisher &Paykel Healthcare , Ltd. · Mar 2009
NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM
K082724 · Newport Medical Instruments, Inc. · Dec 2008
UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV
K071526 · Impact Instrumentation, Inc. · Dec 2008
ENGSTROM CARESTATION, ENGSTROM PRO
K081842 · Datex-Ohmeda, Inc. · Oct 2008