Cleared Traditional

K101262 - FLEXI-LITE

K101262 is an FDA 510(k) clearance for FLEXI-LITE, manufactured by Pressure-Tech, Inc.. The device is a Class 2 Anesthesiology device with product code CBF cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K101262 · Pressure-Tech, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
36d
Days
Class 2
Risk

K101262 is an FDA 510(k) clearance for the FLEXI-LITE. Classified as Chamber, Hyperbaric (product code CBF), Class II - Special Controls.

Submitted by Pressure-Tech, Inc. (Great Neck, US). The FDA issued a Cleared decision on June 10, 2010 after a review of 36 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K101262

510(k) Number K101262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2010
Decision Date June 10, 2010
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 56
Devices cleared under the same product code (CBF) and FDA review panel - the closest regulatory comparables to K101262.
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SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
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RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER
K082455 · Gulf Coast Hyperbarics, Inc. · May 2009
HYPERBARIC AMERICA, LLC, PRESIDENTIAL MONOPLACE HYPERBARIC CHAMBER SYSTEMS
K081506 · Hyperbaric America, LLC · Jul 2008