Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Spectra Platinum

K-Number: K251932 · 2025-11-25

ApplicantUzinmedicare Co., Ltd.
Decision Date2025-11-25
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Spectra Platinum is the device name listed in this FDA 510(k) record. The listed applicant is Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K251932. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Spectra Platinum?

Spectra Platinum is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Uzinmedicare Co., Ltd.. The 510(k) number is K251932.

When did Spectra Platinum receive FDA 510(k) clearance?

Spectra Platinum received FDA 510(k) clearance on 2025-11-25, under 510(k) number K251932.

Who is the listed applicant for Spectra Platinum?

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

What is the FDA product code for Spectra Platinum?

The FDA product code for Spectra Platinum is HGX.

Other records listing Uzinmedicare Co., Ltd. as applicant

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.

K260956Spectra Platinum MiniK250208SPECTRA Wearable 2K251423Spectra S1 Pro; Spectra S2 ProK220926Spectra WearableK210124Synergy Gold (SG) Portable (Models MM011450 and MM011460)K191109Spectra Q

View all 11 devices →

Related Devices (Code: HGX)

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.

K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.K250070Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)Shenzhen Changkun Technology Co., Ltd.K261025Wearable breast pump (QY-101, QY-102, QY-108)Shenzhen Qinyi Electronic Technology Co., Ltd.K254254Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)Shenzhen Root Innovation Technology Co., Ltd.K260538Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )Shenzhen Root Innovation Technology Co., Ltd.

Official Source

View on FDA Database →

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

↑