Product code HGX: 510(k) clearances and predicates

Product code HGX covers Wearable Breast Pump (Model S36). FDA lists 253 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.

Clearance volume

253 clearances on file under product code HGX. Counts by year:

Year	Clearances
2022	15
2023	15
2024	19
2025	26
2026 so far	33

Recent clearances

Newest HGX clearances in the FDA index, with applicant and decision date:

• K254203, Wearable Breast Pump (Model S36), applicant Shenzhen TPH Technology Co., Ltd., decided 2026-09-17. FDA record
• K261622, Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62), applicant Philips Consumer Lifestyle B.V., decided 2026-09-03. FDA record
• K262774, Wearable breast pump (Model: XN/MD-2249BS, ZFHF), applicant Guangdong Horigen Mother & Baby Products Co., Ltd., decided 2026-09-01. FDA record
• K260643, Cimilre Dual Max, applicant Cimilre Co., Ltd., decided 2026-08-21. FDA record
• K261298, Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)), applicant Guangdong Youmeng Electrical Technology Co., Ltd., decided 2026-08-20. FDA record
• K260259, DiscreetDuo™ Flow Wearable Breast Pump (Model S3), applicant Shenzhen TPH Technology Co., Ltd., decided 2026-07-24. FDA record
• K261199, Wearable Breast Pump (Model S32A), applicant Shenzhen TPH Technology Co., Ltd., decided 2026-07-13. FDA record
• K250070, Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3), applicant Shenzhen Changkun Technology Co., Ltd., decided 2026-06-26. FDA record

What this means for a regulatory watcher

Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model: SCF593/52, SCF593/62); Philips Avent Natural Care Warming Hands-free Wearable Electric Breast Pump (Model: SCF594/52, SCF594/62), Wearable breast pump (Model: XN/MD-2249BS, ZFHF). Watch new HGX clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.

FAQ

What is FDA product code HGX?

It is the three letter code FDA assigns to a device type in the 510(k) index. Recent HGX clearances include Wearable Breast Pump (Model S36).

How many 510(k) clearances use product code HGX?

253 at the time this page was generated, from openFDA records.

How do I find a predicate device under HGX?

Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.

How do I track new HGX clearances?

Get 510(k) alerts filtered to this product code and read each new clearance as it posts.

Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.