Cleared Traditional

K232989 - Pulse Oximeter (AOJ-70A)

Also marketed or referenced as:
Pulse Oximeter (AOJ-70B) Pulse Oximeter (AOJ-70C) Pulse Oximeter (AOJ-70D) Pulse Oximeter (AOJ-70E)

K232989 is an FDA 510(k) clearance for Pulse Oximeter (AOJ-70A), manufactured by Shenzhen AOJ 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 283-day FDA review.

K232989 · Shenzhen AOJ Medical Technology Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
283d
Days
Class 2
Risk

K232989 is an FDA 510(k) clearance for the Pulse Oximeter (AOJ-70A). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Shenzhen AOJ Medical Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 1, 2024 after a review of 283 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 Shenzhen AOJ Medical Technology Co., Ltd. devices

FDA 510(k) Submission Details - K232989

510(k) Number K232989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2023
Decision Date July 01, 2024
Days to Decision 283 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
143d slower than avg
Panel avg: 140d · This submission: 283d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K232989.
Pulse Oximeter (WS20A)
K240808 · Hunan Accurate Bio-Medical Technology Co., Ltd. · Oct 2024
OxiWear
K233827 · Oxiwear, Inc. · Aug 2024
Mecun SpO2 sensor
K231979 · Shenzhen Mecun Medical Supply Co., Ltd. · Aug 2024
Pulse Oximeter (MD300C228)
K232975 · Beijing Choice Electronic Technology Co., Ltd. · Jun 2024
ANNE Limb
K240305 · Sibel Health, Inc. · May 2024
AViTA Pulse Oximeter
K223399 · Avita Corporation · May 2024