Cleared Traditional

K181270 - Disposable SpO2 Sensors

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

K181270 · Orantech, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 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 367
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