Cleared Traditional

K181270 - Disposable SpO2 Sensors, Reusable SpO2 Sensors

K181270 is an FDA 510(k) clearance for Disposable SpO2 Sensors, manufactured by Orantech, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K181270 · Orantech, Inc. · Anesthesiology device
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Sep 2018
Decision
116d
Days
Class 2
Risk

K181270 is an FDA 510(k) clearance for the Disposable SpO2 Sensors, Reusable SpO2 Sensors. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Orantech, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 7, 2018 after a review of 116 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 Orantech, Inc. devices

FDA 510(k) Submission Details - K181270

510(k) Number K181270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2018
Decision Date September 07, 2018
Days to Decision 116 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
24d faster than avg
Panel avg: 140d · This submission: 116d
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 Consultant

Mid-Link Consulting Co, Ltd.
Diana Hong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQA Oximeter

All 576
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K181270.
Masimo Rad-97 and Accessories
K180046 · Masimo Corporation · Oct 2018
Fingertip Pulse Oximeter
K181503 · Beijing Choice Electronic Technology Co., Ltd. · Oct 2018
BB-613 Watch Oximeter
K181006 · Bio-Beat Technologies , Ltd. · Sep 2018
Reusable & Disposable SpO2 Sensors
K173368 · Shenzhen Coreray Technology, Ltd. · Aug 2018
Optical Topography System ETG-4100
K172492 · Hitachi Healthcare Americas · Aug 2018
Pulse Oximeter
K173123 · Shenzhen Imdk Medical Technology Co., Ltd. · Aug 2018