510(k) Report

FDA applicant

Guangdong Horigen Mother & Baby Products Co., Ltd.

Shantou, CN7 decisions2016–20260 recalls

FDA records 7 decisions for Guangdong Horigen Mother & Baby Products Co., Ltd. (Shantou, CN) from 2016 to 2026: 7 510(k) clearances. Most are in product codes HGX (Pump, Breast, Powered) and FXX (Mask, Surgical). Since 2016 its 510(k)s took a median of 235 days from receipt to decision, against 158 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Guangdong Horigen Mother & Baby Products Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 12019: 12020: 12021: 22022: 12026 (partial year): 1
2016high 2 (2021) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Guangdong Horigen Mother & Baby Products Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Guangdong Horigen Mother & Baby…’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • HGXPump, Breast, Powered6decisions
  • FXXMask, Surgical1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 235 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 158 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201152Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 20211cites it
  • K182413Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K262774Wearable breast pump (Model: XN/MD-2249BS, ZFHF)Guangdong Horigen Mother & Baby Products Co., Ltd. · 2026
  • K212564Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2022
  • K201152Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2021
  • K201974Single-use medical face maskGuangdong Horigen Mother & Baby Products Co., Ltd. · 2021
  • K193449Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01)Guangdong Horigen Mother & Baby Products Co., Ltd. · 2020
  • K182413Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2019
  • K162747Proture Double Electric Breast PumpGuangdong Horigen Mother & Baby Products Co., Ltd. · 2016

All 7 as Guangdong Horigen Mother & Baby Products Co., Ltd. →