Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)

FDA 510(k) K222213 · Unimed Medical Supplies, Inc.

Substantially Equivalent

510(k) numberK222213

Submission

Device name
Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104)
Applicant
Unimed Medical Supplies, Inc.
Shenzhen, CN
Received
July 25, 2022
Decision date
December 19, 2022
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
K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes…FLL · Traditional 06/05/2026SE
K260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)DQA · Special 04/14/2026SE
K253964Disposable Neonatal NIBP Cuff (U1681S-C51N)DXQ · Special 01/09/2026SE
K251696Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2…DQA · Traditional 12/01/2025SE
K251691Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08…DQA · Traditional 12/01/2025SE
K251695Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Sensors (-06…DQA · Traditional 11/18/2025SE
K251693Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensors (-75…DQA · Traditional 11/18/2025SE
K250931Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable SpO2…DQA · Traditional 08/13/2025SE
K251045Disposable Neonatal NIBP Cuff (U1682S-C51N); Disposable Neonatal NIBP Cuff…DXQ · Traditional 07/15/2025SE
K243086Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable…DQA · Traditional 02/20/2025SE

Questions and answers

When was Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) cleared by the FDA?

Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) (K222213) received a 510(k) decision of Substantially Equivalent on December 19, 2022, 147 days after the submission was received.

What is the product code of K222213?

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