Cleared Traditional

TESLAOXYSAT, MODEL EFOXYSATE (K050018) - FDA 510(k) Clearance

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

K050018 · Mammendorfer Institute For Physics & Medicine GmbH · Anesthesiology device
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Jul 2005
Decision
178d
Days
Class 2
Risk

K050018 is an FDA 510(k) clearance for the TESLAOXYSAT, MODEL EFOXYSATE. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Mammendorfer Institute For Physics & Medicine GmbH (Golden, US). The FDA issued a Cleared decision on July 1, 2005 after a review of 178 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Mammendorfer Institute For Physics & Medicine GmbH devices

Submission Details

510(k) Number K050018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 2005
Decision Date July 01, 2005
Days to Decision 178 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
38d slower than avg
Panel avg: 140d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 243
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