Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Shenzhen TPH Technology Co., Ltd. — Predicate Candidate Screening

23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

133 daysmedian FDA review time
196 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260259DiscreetDuo™ Flow Wearable Breast Pump (Model S3)Shenzhen TPH Technology Co., Ltd.2026-07-241770
K261199Wearable Breast Pump (Model S32A)Shenzhen TPH Technology Co., Ltd.2026-07-13910
K260864Mother's Nature W1 Warming Wearable Breast PumpShenzhen TPH Technology Co., Ltd.2026-06-09840
K254244Wearable Breast Pump (Model S39)Shenzhen TPH Technology Co., Ltd.2026-05-211430
K260033Wearable Breast Pump (Model S21A)Shenzhen TPH Technology Co., Ltd.2026-04-08920
K252422Wearable Breast Pump (Model W2)Shenzhen TPH Technology Co., Ltd.2026-02-131960
K252420Wearable Breast Pump (Model W12)Shenzhen TPH Technology Co., Ltd.2026-02-131960
K251754Wearable Breast Pump (Model S33)Shenzhen TPH Technology Co., Ltd.2025-09-08910
K250383Wearable Breast Pump (Model W6)Shenzhen TPH Technology Co., Ltd.2025-08-201900
K250843Wearable Breast Pump (Model FS12A); Wearable Breast Pump (MoShenzhen TPH Technology Co., Ltd.2025-07-311330
K250350Thrive 2-in-1 Breast Pump (Model P3)Shenzhen TPH Technology Co., Ltd.2025-07-151580
K250368Wearable Breast Pump (Model S21)Shenzhen TPH Technology Co., Ltd.2025-05-301090
K250365Motif Aura Glow breast pump (Model Motif Aura Glow)Shenzhen TPH Technology Co., Ltd.2025-05-301090
K243508Wearable breast pump (model S12A)Shenzhen TPH Technology Co., Ltd.2025-04-211600
K250829Lacevo Wearable Breast Pump (Model S70)Shenzhen TPH Technology Co., Ltd.2025-04-17290
K250152eufy Wearable Breast Pump S1 (T8D02) Model T8D02; eufy WearaShenzhen TPH Technology Co., Ltd.2025-04-02710
K250463Ameda GLO Wearable Breast Pump (Model W8S)Shenzhen TPH Technology Co., Ltd.2025-03-20300
K242850Wearable breast pump (model W8)Shenzhen TPH Technology Co., Ltd.2025-02-211540
K240536Wearable Breast Pump (Model S32)Shenzhen TPH Technology Co., Ltd.2024-07-011260
K223886Wearable Breast Pump (Model S18)Shenzhen TPH Technology Co., Ltd.2023-07-141990
K222045Wearable Breast Pump (Model S1DW)Shenzhen TPH Technology Co., Ltd.2023-01-041770
K220596Wearable Breast Pump (Model S9)Shenzhen TPH Technology Co., Ltd.2022-05-26860
K212180Wearable Breast Pump (Model S12)Shenzhen TPH Technology Co., Ltd.2022-02-112140

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda