Playtex Breast Pump
FDA 510(k) K022594 · Playtex Products, Inc.
510(k) numberK022594
Submission
- Device name
- Playtex Breast Pump
- Applicant
- Playtex Products, Inc.
Allendale, NJ, US - Received
- August 5, 2002
- Decision date
- November 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HGX – Pump, Breast, Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5160
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HGX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261622 | Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52…HGX · Traditional | Philips Consumer Lifestyle B.V. | 09/03/2026SE |
| K262774 | Wearable breast pump (Model: XN/MD-2249BS, ZFHF)HGX · Traditional | Guangdong Horigen Mother & Baby Products Co., Ltd. | 09/01/2026SE |
| K260643 | Cimilre Dual MaxHGX · Traditional | Cimilre Co., Ltd. | 08/21/2026SE |
| K261298 | Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42))HGX · Traditional | Guangdong Youmeng Electrical Technology Co., Ltd. | 08/20/2026SE |
| K260259 | DiscreetDuo Flow Wearable Breast Pump (Model S3)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/24/2026SE |
| K261199 | Wearable Breast Pump (Model S32A)HGX · Traditional | Shenzhen TPH Technology Co., Ltd. | 07/13/2026SE |
| K250070 | Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3)HGX · Traditional | Shenzhen Changkun Technology Co., Ltd. | 06/26/2026SE |
| K261025 | Wearable breast pump (QY-101, QY-102, QY-108)HGX · Traditional | Shenzhen Qinyi Electronic Technology Co., Ltd. | 06/25/2026SE |
| K254254 | Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D)HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/18/2026SE |
| K260538 | Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D )HGX · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 06/17/2026SE |
More from Shenzhen Root Innovation Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K073662 | Playtex Gentile Glide, Playtex Gentile Glide Multipack TamponsHIL · Special | 01/17/2008SE |
| K072376 | Playtex Gentle Glide, Playtex Gentle Glide Multipack TamponsHIL · Traditional | 12/12/2007SE |
| K070745 | Modification to: Playtex Gentle Glide Plastic, Playtex Gentle Plastic Multipack TamponsHIL · Special | 04/13/2007SE |
| K061013 | Playtex Embrace Petite Breast PumpHGX · Traditional | 08/15/2006SE |
| K060981 | Playtex Sport Plastic, Playtex Sport Plastic Multipack TamponsHIL · Special | 05/09/2006SE |
| K032636 | Playtex Unscented Cardboard Applicator Tampon #13203 (Colored) and # 13203 PV…HEB · Traditional | 11/14/2003SE |
| K022882 | Modification to Playtex Tampons #24002HIL · Special | 09/16/2002SE |
| K020200 | Playtex Deodorant Tampons, Model 34802HIL · Traditional | 03/13/2002SE |
| K020202 | Playtex Deodorant Tampons, Model 34702HIL · Traditional | 03/12/2002SE |
| K020201 | Playtex Deodorant Tampons, Model 34902HIL · Traditional | 03/12/2002SE |
Questions and answers
When was Playtex Breast Pump cleared by the FDA?
Playtex Breast Pump (K022594) received a 510(k) decision of Substantially Equivalent on November 1, 2002, 88 days after the submission was received.
What is the product code of K022594?
The FDA product code is HGX – Pump, Breast, Powered, a Class II (moderate risk) device regulated under 21 CFR 884.5160.