Cleared Special

K111494 - HANDHELD PULSE OXIMETER

K111494 is an FDA 510(k) clearance for HANDHELD PULSE OXIMETER, manufactured by Beijing Choice Electronic Technololgy Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 232-day FDA review.

K111494 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Jan 2012
Decision
232d
Days
Class 2
Risk

K111494 is an FDA 510(k) clearance for the HANDHELD 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 January 18, 2012 after a review of 232 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.

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

FDA 510(k) Submission Details - K111494

510(k) Number K111494 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date January 18, 2012
Days to Decision 232 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
92d slower than avg
Panel avg: 140d · This submission: 232d
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 613
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K111494.
PULTOL
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