Cleared Abbreviated

K121806 - BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTWARE

K121806 is an FDA 510(k) clearance for BESIDE RESPIRATORY PATIENT MONITORING S..., manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Abbreviated 510(k) pathway after a 100-day FDA review.

K121806 · Covidien · Anesthesiology device
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Sep 2012
Decision
100d
Days
Class 2
Risk

K121806 is an FDA 510(k) clearance for the BESIDE RESPIRATORY PATIENT MONITORING SYSTEM BESIDE RESIRATORY PATIENT MONITO.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on September 28, 2012 after a review of 100 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 Covidien devices

FDA 510(k) Submission Details - K121806

510(k) Number K121806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2012
Decision Date September 28, 2012
Days to Decision 100 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
40d faster than avg
Panel avg: 140d · This submission: 100d
Pathway characteristics
Standards-based clearance path.

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 678
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