Cleared Abbreviated

K081800 - T12S TELEMETRY TRANSMITTER

K081800 is the FDA 510(k) clearance for T12S TELEMETRY TRANSMITTER by Mortara Instrument, Inc.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Abbreviated 510(k) pathway after a 91-day FDA review.

K081800 · Mortara Instrument, Inc. · Anesthesiology device
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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.

View all Mortara Instrument, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 140d · 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 337
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K081800.
N-600X WITH SPD, OXIMAX N-600X
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K081937 · Philips Medizin Systeme Boeblingen GmbH · Aug 2008
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K081285 · Nonin Medical, Inc. · Jun 2008