Cleared Abbreviated

K081800 - T12S TELEMETRY TRANSMITTER (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K081800 · Mortara Instrument, Inc. · Anesthesiology device
Sep 2008
Decision
91d
Days
Class 2
Risk

K081800 is an FDA 510(k) clearance for the T12S TELEMETRY TRANSMITTER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Mortara Instrument, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 24, 2008 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

Submission Details

510(k) Number K081800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2008
Decision Date September 24, 2008
Days to Decision 91 days
Submission Type Abbreviated
Review Panel Anesthesiology (AN)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
134d faster than avg
Panel avg: 225d · This submission: 91d
Pathway characteristics
Standards-based clearance path.

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 20
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K081800.
AViTA Pulse Oximeter (SP61)
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