Cleared Special

K093757 - MD300C1 FINGERTIP PULSE OXIMETER

K093757 is the FDA 510(k) clearance for MD300C1 FINGERTIP PULSE OXIMETER by Beijing Choice Electronic Technololgy Co., Ltd.. It is a Class 2 Anesthesiology device (product code DQA) cleared through the Special 510(k) pathway after a 86-day FDA review.

K093757 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Mar 2010
Decision
86d
Days
Class 2
Risk

K093757 is an FDA 510(k) clearance for the MD300C1 FINGERTIP PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Shijingshan District, Beijing, CN). The FDA issued a Cleared decision on March 3, 2010 after a review of 86 days - a notably fast clearance 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beijing Choice Electronic Technololgy Co., Ltd. devices

Submission Details

510(k) Number K093757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2009
Decision Date March 03, 2010
Days to Decision 86 days
Submission Type Special
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
54d faster than avg
Panel avg: 140d · This submission: 86d
Pathway characteristics
Modification to existing cleared device.

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 403
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K093757.
LNCS OXIMETRY SENSORS, REPROCESSED LNCS OXIMETRY SENSORS
K094046 · Masimo Corporation · May 2010
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
K093881 · GE Healthcare Finland Oy · Mar 2010
SINGLE-PATIENT USE DISPOSABLE SENSOR
K093306 · Nonin Medical, Inc. · Mar 2010
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA
K092652 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2010
MD300C318 FINGERTIP PULSE OXIMETER
K092620 · Beijing Choice Electronic Technololgy Co., Ltd. · Dec 2009
H100B PULSE OXIMETER
K092727 · Edan Instruments, Inc. · Dec 2009