Cleared Traditional

K151206 - Fingertip Pulse Oximeter

K151206 is an FDA 510(k) clearance for Fingertip 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 Traditional 510(k) pathway after a 114-day FDA review.

K151206 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
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Aug 2015
Decision
114d
Days
Class 2
Risk

K151206 is an FDA 510(k) clearance for the Fingertip Pulse Oximeter. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on August 28, 2015 after a review of 114 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Beijing Choice Electronic Technololgy Co., Ltd. devices

FDA 510(k) Submission Details - K151206

510(k) Number K151206 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2015
Decision Date August 28, 2015
Days to Decision 114 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
26d faster than avg
Panel avg: 140d · This submission: 114d
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 613
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K151206.
Finger Type Pulse Oximeter
K151024 · Taidoc Technology Corporation · Mar 2016
Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D
K151287 · Guangdong Biolight Meditech Co., Ltd. · Jan 2016
Masimo MightySat Rx Fingertip Pulse Oximeter
K150314 · Masimo Corporation · Oct 2015
Pulse Oximeter, Models PC-66A
K150093 · Shenzhen Creative Industry Co., Ltd. · Jun 2015
PULSE OXIMETER CMS50EW
K141362 · Contec Medical Systems Co.,Ltd · Apr 2015
Pulse Oximeter
K142687 · Shanghai Berry Electronic Tech Co., Ltd. · Apr 2015