Cleared Special

K133090 - OXICARE FINGERTIP PULSE OXIMETER

K133090 is an FDA 510(k) clearance for OXICARE FINGERTIP PULSE OXIMETER, manufactured by Delbio Incorporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 151-day FDA review.

K133090 · Delbio Incorporation · Anesthesiology device
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Feb 2014
Decision
151d
Days
Class 2
Risk

K133090 is an FDA 510(k) clearance for the OXICARE FINGERTIP PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Delbio Incorporation (Fremont City, US). The FDA issued a Cleared decision on February 28, 2014 after a review of 151 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - the FDA anesthesiology and respiratory device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K133090

510(k) Number K133090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date February 28, 2014
Days to Decision 151 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d slower than avg
Panel avg: 140d · This submission: 151d
Pathway characteristics
Modification to existing cleared device.

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 687
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K133090.
FINGERTIP PULSE OXIMETER
K140682 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2014
PULSE OXIMETER
K140785 · Nonin Medical, Inc. · Jul 2014
MYSIGN S PULSE OXIMETER, MYSIGN PC SOFTWARE (OPTIONAL), SOFTTIP LARGE R-3211-31, FINGER CLIP F-3211-31
K133064 · Envitec-Wismar GmbH · May 2014
SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM
K132402 · Nonin Medical, Inc. · Feb 2014
BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM WITH RESPIRATION RATE SOFTW
K130320 · Covidien · Feb 2014
NBM-200MP
K124041 · Orsense, Ltd. · Oct 2013