Perifit Pump 15mm
Perifit Pump 15mm is a Class II device made by X6 Innovations, cleared under FDA 510(k) K231785 on 26 Jan 2024 and listed in FDA GUDID since 8 Mar 2024 (UDI-DI 03770014642233), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03770014642233 | Date8 Mar 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK231785 | Date26 Jan 2024 | StatusActive |
Official records
- AccessGUDID record 03770014642233
- FDA 510(k) database K231785
Across registries
- FDA 510(k) K231785 decided 26 Jan 2024 Active
- FDA GUDID UDI-DI 03770014642233 listed 8 Mar 2024 Listed
Timeline
- Cleared FDA 510(k) K231785
- Listed FDA GUDID 03770014642233
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Perifit Pump
- Generic name
- Breast pump, electric
- Model / reference
- Perifit Pump 15mm
- Primary DI / UDI-DI
- 03770014642233
- 510(k) Number
- FDA product code
- HGX
- GMDN term
- Breast pump, electric
- Device class
- Class II
- Regulation number
- 884.5160
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HGX (Pump, Breast, Powered).
- Hi bebe Super (BT-150B) by Bistos Co., Ltd.
- LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002 by Limerick, Inc.
- Willow Generation 3 Breast Pump by WILLOW INNOVATIONS, INC.
- VIVACE by Unimom.Co
- Medela Family Pump Control 101046623 by Medela AG
- Wearable Breast Pump (Model S18) by Shenzhen TPH Technology Co., Ltd
- Electric breast pump (Models: RH-228 and RH-338) by Cixi Ruihong Electric Appliance Co., Ltd.
- Naya Breast Pump System by Naya Health, Inc.
- Hygeia Express Powered Breast Pump by HYGEIA II MEDICAL GROUP, INC.
- CLOSER TO NATURE ELECTRIC BREAST PUMP by Mayborn Group Limited