Cleared Traditional

K051759 - FLEXI-LITE

K051759 is an FDA 510(k) clearance for FLEXI-LITE, manufactured by Performance Hyperbarics. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K051759 · Performance Hyperbarics · Anesthesiology device
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Nov 2005
Decision
141d
Days
Class 2
Risk

K051759 is an FDA 510(k) clearance for the FLEXI-LITE, MODEL FL-V1.2. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Performance Hyperbarics (Makawao, US). The FDA issued a Cleared decision on November 17, 2005 after a review of 141 days - within the typical 510(k) review window.

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 Performance Hyperbarics devices

FDA 510(k) Submission Details - K051759

510(k) Number K051759 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2005
Decision Date November 17, 2005
Days to Decision 141 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
1d slower than avg
Panel avg: 140d · This submission: 141d
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
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