Home / 510(k) Clearances / K220926

510(k) K220926

Spectra Wearable by Uzinmedicare Co., Ltd. — Product Code HGX

K220926 is an FDA 510(k) premarket notification submitted by Uzinmedicare Co., Ltd. for the device "Spectra Wearable". The FDA issued a decision of Substantially Equivalent on December 12, 2022. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Uzinmedicare Co., Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2022
Date Received
March 31, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

Other clearances by Uzinmedicare Co., Ltd.

  • K260956 — Spectra Platinum Mini (June 4, 2026)
  • K250208 — SPECTRA Wearable 2 (April 6, 2026)
  • K251423 — Spectra S1 Pro; Spectra S2 Pro (February 6, 2026)
  • K251932 — Spectra Platinum (November 25, 2025)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (September 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF5 (September 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (September 1, 2026)
  • K260643 — Cimilre Dual Max (August 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (August 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (July 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (July 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (June 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (June 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (June 18, 2026)

FDA data resources