Pulse Oximeter

FDA 510(k) K172141 · Shanghai Berry Electronic Tech Co., Ltd.

Substantially Equivalent

510(k) numberK172141

Submission

Device name
Pulse Oximeter
Applicant
Shanghai Berry Electronic Tech Co., Ltd.
Shanghai, CN
Received
July 17, 2017
Decision date
April 4, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DQA – Oximeter
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2700
Specialty
Cardiovascular

Other 510(k)s with product code DQA

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K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m)…DQA · Traditional Philips Medizin Systeme Böblingen GmbH05/29/2026SE
K252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO…DQA · Traditional Shenzhen Imdk Medical Technology Co., Ltd.05/11/2026SE
K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar…DQA · Traditional Philips Medizin Systeme05/01/2026SE
K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special Unimed Medical Supplies, Inc.04/14/2026SE
K252448AViTA Pulse Oximeter (SP61)DQA · Traditional Avita Corporation02/27/2026SE
K252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)DQA · Traditional Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.02/17/2026SE
K253109Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)DQA · Traditional Shenzhen Best Electronics Co., Ltd.01/07/2026SE
K251751Spo2 Sensor CSS032DDQA · Traditional Shenzhen Ykd Technology Co., Ltd.12/19/2025SE
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional Unimed Medical Supplies, Inc.12/01/2025SE
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional Unimed Medical Supplies, Inc.12/01/2025SE

More from Unimed Medical Supplies, Inc.

510(k)DeviceDecision
K250837Pulse OximeterDQA · Traditional 09/25/2025SE
K142687Pulse OximeterDQA · Traditional 04/13/2015SE

Questions and answers

When was Pulse Oximeter cleared by the FDA?

Pulse Oximeter (K172141) received a 510(k) decision of Substantially Equivalent on April 4, 2018, 261 days after the submission was received.

What is the product code of K172141?

The FDA product code is DQA – Oximeter, a Class II (moderate risk) device regulated under 21 CFR 870.2700.