Cleared Traditional

K101286 - SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04 (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101286 · Linde Healthcare AB · Anesthesiology device
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Oct 2011
Decision
531d
Days
Class 2
Risk

K101286 is an FDA 510(k) clearance for the SEDARA GAS MIXER, SEDARA SCAVENGER MODEL: 03, 04. Classified as Mixer, Breathing Gases, Anesthesia Inhalation (product code BZR), Class II - Special Controls.

Submitted by Linde Healthcare AB (Lidingo, SE). The FDA issued a Cleared decision on October 20, 2011 after a review of 531 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

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Submission Details

510(k) Number K101286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2010
Decision Date October 20, 2011
Days to Decision 531 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
392d slower than avg
Panel avg: 139d · This submission: 531d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
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