Cleared Traditional

K130320 - BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW

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.

View all Covidien devices

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 665
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K130320.
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
K133064 · Envitec-Wismar GmbH · May 2014
OXICARE FINGERTIP PULSE OXIMETER
K133090 · Delbio Incorporation · Feb 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · Nonin Medical, Inc. · Feb 2014
NBM-200MP
K124041 · Orsense, Ltd. · Oct 2013
FINGERTIP PULSE OXIMETER
K131047 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013
FINGERTIP PULSE OXIMETER
K130947 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2013