Cleared Traditional

K041007 - MILLENIUM

K041007 is an FDA 510(k) clearance for MILLENIUM, manufactured by Hyperbaric For Life, LLC. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K041007 · Hyperbaric For Life, LLC · Anesthesiology device
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Nov 2004
Decision
210d
Days
Class 2
Risk

K041007 is an FDA 510(k) clearance for the MILLENIUM, MODELS 2000, 2001 AND 2002. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Hyperbaric For Life, LLC (Phoenix, US). The FDA issued a Cleared decision on November 15, 2004 after a review of 210 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5470 - 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 Hyperbaric For Life, LLC devices

FDA 510(k) Submission Details - K041007

510(k) Number K041007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2004
Decision Date November 15, 2004
Days to Decision 210 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 140d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBF Device Classification - Class 2, Special Controls

Product Code CBF Chamber, Hyperbaric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5470
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 - CBF Chamber, Hyperbaric

All 10
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K041007.
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