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FDA 510(k)

Spo2 Sensor CSS032D

K-Number: K251751 · 2025-12-19

ApplicantShenzhen Ykd Technology Co., Ltd.
Decision Date2025-12-19
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Spo2 Sensor CSS032D is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ykd Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under 510(k) number K251751. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spo2 Sensor CSS032D?

Spo2 Sensor CSS032D is a medical device that received FDA 510(k) clearance on 2025-12-19. The listed applicant is Shenzhen Ykd Technology Co., Ltd.. The 510(k) number is K251751.

When did Spo2 Sensor CSS032D receive FDA 510(k) clearance?

Spo2 Sensor CSS032D received FDA 510(k) clearance on 2025-12-19, under 510(k) number K251751.

Who is the listed applicant for Spo2 Sensor CSS032D?

The FDA 510(k) record lists Shenzhen Ykd Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Spo2 Sensor CSS032D?

The FDA product code for Spo2 Sensor CSS032D is DQA.

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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