Cleared Traditional

ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS (K043463) - FDA 510(k) Clearance

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

K043463 · Envitec-Wismar GmbH · Anesthesiology device
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Feb 2005
Decision
58d
Days
Class 2
Risk

K043463 is an FDA 510(k) clearance for the ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Envitec-Wismar GmbH (Egale, US). The FDA issued a Cleared decision on February 11, 2005 after a review of 58 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Envitec-Wismar GmbH devices

Submission Details

510(k) Number K043463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date February 11, 2005
Days to Decision 58 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
82d faster than avg
Panel avg: 140d · This submission: 58d
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 190
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