Spectra S1 Pro; Spectra S2 Pro
K-Number: K251423 · 2026-02-06
ApplicantUzinmedicare Co., Ltd.
Decision Date2026-02-06
Product CodeHGX
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Spectra S1 Pro; Spectra S2 Pro is a medical device manufactured by Uzinmedicare Co., Ltd.. It received FDA 510(k) clearance on 2026-02-06 under approval number K251423. 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 S1 Pro; Spectra S2 Pro?
Spectra S1 Pro; Spectra S2 Pro is a medical device that received FDA 510(k) clearance on 2026-02-06. It is manufactured by Uzinmedicare Co., Ltd.. The 510(k) number is K251423.
When was Spectra S1 Pro; Spectra S2 Pro approved by the FDA?
Spectra S1 Pro; Spectra S2 Pro received FDA 510(k) clearance on 2026-02-06, under approval number K251423.
What company makes Spectra S1 Pro; Spectra S2 Pro?
Spectra S1 Pro; Spectra S2 Pro is manufactured by Uzinmedicare Co., Ltd..
What is the FDA product code for Spectra S1 Pro; Spectra S2 Pro?
The FDA product code for Spectra S1 Pro; Spectra S2 Pro is HGX.
Other Devices by Uzinmedicare Co., Ltd.
Related Devices (Code: HGX)
K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd.
K161725Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retailMedela, Inc.
K160274Hi bebe plusBistos Co., Ltd.
K161532Philips Avent Comfort Single/Twin Electric Breast PumpPhilips Consumer Lifestyle - Innovation Site Eindhoven
K161266Athena Breast PumpExploramed Nc7, Inc.
K160511Naya Breast Pump SystemNaya Health, Inc.
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.