Cleared Traditional

K141105 - PULSE OXIMETER

K141105 is an FDA 510(k) clearance for PULSE OXIMETER, manufactured by Hunan Accurate Bio-Medical Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K141105 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
219d
Days
Class 2
Risk

K141105 is an FDA 510(k) clearance for the PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Hunan Accurate Bio-Medical Technology Co., Ltd. (Changsha, Hunan, CN). The FDA issued a Cleared decision on December 4, 2014 after a review of 219 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. 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 Hunan Accurate Bio-Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K141105

510(k) Number K141105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 2014
Decision Date December 04, 2014
Days to Decision 219 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 140d · This submission: 219d
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 454
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K141105.
Nellcor Bedside Respiratory Patient Monitoring System
K141518 · Covidien · Mar 2015
Fingertip Pulse Oximeter
K142888 · Beijing Choice Electronic Technololgy Co., Ltd. · Feb 2015
EXTERNAL PULSE OXIMETER
K141024 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2015
NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS )
K141542 · Covidien, LLC · Oct 2014
FINGERTIP PULSE OXIMETER
K141128 · Beijing Choice Electronic Technololgy Co., Ltd. · Aug 2014
FINGERTIP PULSE OXIMETER
K140682 · Beijing Choice Electronic Technololgy Co., Ltd. · Jul 2014