Chrysalis Intelligence · Sponsors · Shenzhen Root Innovation Technology Co., Ltd.

Shenzhen Root Innovation Technology Co., Ltd.

Shenzhen, CN · 12 510(k) clearances

Total clearances
12
2024-03-06 → 2026-06-18
Last 12 months
10
Product codes
2
Most recent
2026-06-18
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
HGX Pump, Breast, Powered Class II Obstetrics/Gynecology 10 2026-06-18
BTA 2 2026-05-26
Filings

All 510(k) clearances (12)

Date K-number Device Code Class Specialty
2026-06-18 K254254 Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) HGX Class II Obstetrics/Gynecology
2026-06-17 K260538 Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) HGX Class II Obstetrics/Gynecology
2026-05-26 K253629 Momcozy Nasal Aspirator (BN007) BTA
2026-05-15 K260134 Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021) BTA
2026-04-29 K253914 Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) HGX Class II Obstetrics/Gynecology
2026-04-08 K254258 Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) HGX Class II Obstetrics/Gynecology
2026-04-07 K253946 Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) HGX Class II Obstetrics/Gynecology
2026-03-09 K253934 Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) HGX Class II Obstetrics/Gynecology
2025-10-29 K253283 Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) HGX Class II Obstetrics/Gynecology
2025-09-08 K251394 Momcozy Wearable Breast Pump (BP223) HGX Class II Obstetrics/Gynecology
2024-12-20 K241680 Momcozy Wearable Breast Pump (BP311) HGX Class II Obstetrics/Gynecology
2024-03-06 K233880 Momcozy Wearable Breast Pump (BP137); Momcozy Wearable Breast Pump (BP141) HGX Class II Obstetrics/Gynecology