# Shenzhen Root Innovation Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 13 (2024–2026): 13 510(k) clearances
- Names in FDA's records: Shenzhen Root Innovation Technology Co., Ltd. (12); Shenzhen Root Innovation Technology Co., , Ltd. (1)
- Product codes: HGX (11), BTA (2)
- 510(k) review time since 2016: median 119 days, against 142 for FDA's reviews in the same codes and years (7 of 13 faster)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 4 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Joytech Healthcare Co., Ltd.: 5 (https://510kreport.com/company/joytech-healthcare)
- Avita Corporation: 2 (https://510kreport.com/company/avita)
- Geon Corporation: 1 (https://510kreport.com/company/geon)
- Shenzhen Desida Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-desida-technology)
- Sunrise Medical Hhg, Inc.: 1 (https://510kreport.com/company/sunrise-medical-hhg)

## Firms that cite its devices most
- Anker Innovations Limited: 1 (https://510kreport.com/company/anker-innovations)

## Its most-cited devices
- K251394: Momcozy Wearable Breast Pump (BP223) (2025), cited by 3
- K253283: Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) (2025), cited by 1

## Recent decisions
- K254254: Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (Jun 18, 2026)
- K260538: Momcozy Wearable Breast Pump (BP420, BP420-A, BP420-B, BP420-C, BP420-D ) (Jun 17, 2026)
- K253629: Momcozy Nasal Aspirator (BN007) (May 26, 2026)
- 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) (May 15, 2026)
- K253914: Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) (Apr 29, 2026)
- 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) (Apr 8, 2026)
- 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) (Apr 7, 2026)
- K253934: Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) (Mar 9, 2026)

Source page: https://510kreport.com/company/shenzhen-root-innovation-technology