Cleared Traditional

K231895 - Maxtec MaxBlend2+p

K231895 is an FDA 510(k) clearance for Maxtec MaxBlend2+p, manufactured by Maxtec, LLC. The device is a Class 2 Anesthesiology device with product code BZR cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K231895 · Maxtec, LLC · Anesthesiology device
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Dec 2023
Decision
159d
Days
Class 2
Risk

K231895 is an FDA 510(k) clearance for the Maxtec MaxBlend2+p. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Maxtec, LLC (Salt Lake City, US). The FDA issued a Cleared decision on December 4, 2023 after a review of 159 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5330 - 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 Maxtec, LLC devices

FDA 510(k) Submission Details - K231895

510(k) Number K231895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2023
Decision Date December 04, 2023
Days to Decision 159 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
19d slower than avg
Panel avg: 140d · This submission: 159d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZR Device Classification - Class 2, Special Controls

Product Code BZR Mixer, Breathing Gases, Anesthesia Inhalation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5330
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 - BZR Mixer, Breathing Gases, Anesthesia Inhalation

All 22
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