Cleared Traditional

K050018 - TESLAOXYSAT

K050018 is an FDA 510(k) clearance for TESLAOXYSAT, manufactured by Mammendorfer Institute For Physics & Medicine GmbH. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K050018 · Mammendorfer Institute For Physics & Medicine GmbH · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K050018

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.

DQA Device Classification - Class 2, Special Controls

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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K050018.
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MODIFICATION TO LNCS OXIMETRY SENSORS
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K050844 · Cas Medical Systems, Inc. · Jun 2005
MODEL 2500A PALMSAT PULSE OXIMETER
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K051107 · Nonin Medical, Inc. · Jun 2005