Cleared Traditional

K130320 - BEDSIDE RESPIRATORY PATIENT MONITORING ...

K130320 is an FDA 510(k) clearance for BEDSIDE RESPIRATORY PATIENT MONITORING ..., manufactured by Covidien. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 361-day FDA review.

K130320 · Covidien · Anesthesiology device
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Feb 2014
Decision
361d
Days
Class 2
Risk

K130320 is an FDA 510(k) clearance for the BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MO.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on February 4, 2014 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K130320

510(k) Number K130320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2013
Decision Date February 04, 2014
Days to Decision 361 days
Submission Type Traditional
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
221d slower than avg
Panel avg: 140d · This submission: 361d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K130320.
FINGERTIP PULSE OXIMETER
K140682 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2014
PULSE OXIMETER
K140785 · Nonin Medical, Inc. · Jul 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · Nonin Medical, Inc. · Feb 2014
FINGERTIP PULSE OXIMETER
K131047 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013
FINGERTIP PULSE OXIMETER
K130947 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013
TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
K132696 · GE Healthcare Finland Oy · Sep 2013