# Promisemed Hangzhou Meditech Co., Ltd.

- Location (FDA's records): Hangzhou City, CN
- FDA decisions: 36 (2017–2026): 36 510(k) clearances
- Product codes: FMI (13), FMF (7), FMK (5), KNW (3), PTI (3), JKA (1), MMK (1), FBK (1), PKL (1), QRL (1)
- 510(k) review time since 2016: median 107 days, against 143 for FDA's reviews in the same codes and years (20 of 33 faster)
- Predicates its devices cite: 39 (18 its own); citations of its devices by later devices: 40 (18 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
- Medax Srl Unipersonale: 2 (https://510kreport.com/company/medax-unipersonale)
- Medipurpose Pte., Ltd.: 2 (https://510kreport.com/company/medipurpose)
- Sol-Millennium Medical, Inc.: 2 (https://510kreport.com/company/sol-millennium-medical)
- Corbin Clinical Resources, LLC: 1 (https://510kreport.com/company/corbin-clinical-resources)
- Micropoint Technologies Pte, Ltd.: 1 (https://510kreport.com/company/micropoint-technologies)
- Wenzhou Beipu Science & Technology Co., Ltd.: 1 (https://510kreport.com/company/wenzhou-beipu-science-technology)
- Artsana S.P.A: 1 (https://510kreport.com/company/artsana)
- B.Braun Medical, Inc.: 1 (https://510kreport.com/company/b-braun-medical)

## Firms that cite its devices most
- SteriLance Medical (Suzhou), Inc.: 3 (https://510kreport.com/company/sterilance-medical-suzhou)
- Hantech Medical Device Co., Ltd.: 2 (https://510kreport.com/company/hantech-medical-device)
- Tianjin Huahong Technology Co., Ltd.: 2 (https://510kreport.com/company/tianjin-huahong-technology)
- Shanghai Carelife International Trading Co., Ltd.: 1 (https://510kreport.com/company/shanghai-carelife-international-trading)
- Hebei Xinle Sci&Tech Co., Ltd.: 1 (https://510kreport.com/company/hebei-xinle-sci-tech)
- Spm Medicare Pvt., Ltd.: 1 (https://510kreport.com/company/spm-medicare-pvt)
- Zhejiang Curaway Medical Technology Co., Ltd.: 1 (https://510kreport.com/company/zhejiang-curaway-medical-technology)
- Hh Global Technology, Inc.: 1 (https://510kreport.com/company/hh-global-technology)

## Its most-cited devices
- K192666: Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (2019), cited by 12
- K161950: Common Type Insulin Pen Needle, Safety Type Insulin Pen Needle (2017), cited by 6
- K221368: Promisemed Blood Lancet,  VeriFine Safety Lancet, VeriFine Mini-Safety Lancet (2022), cited by 4
- K193009: Promisemed Heel Blood Lancet (2019), cited by 2
- K220129: Promisemed X-Safety Pen Needle (2022), cited by 2
- K223453: Insulin Syringe (2023), cited by 2

## Recent decisions
- K261719: Promisemed X-Safety Pen Needle (Aug 25, 2026)
- K261196: Promisemed VeriEcto Automatic Biopsy Needles (May 12, 2026)
- K261045: Verifine Safety Lancets (May 1, 2026)
- K254273: Verisafe Safety Sterile Needles (SSN) (Apr 16, 2026)
- K250192: Verisafe Safety Retractable Insulin Syringes (Dec 10, 2025)
- K250961: Blood collection tube holders (Jun 4, 2025)
- K251138: Promisemed Safety Huber Needles (May 13, 2025)
- K243332: Promisemed Safety Huber Needles (Mar 14, 2025)

Source page: https://510kreport.com/company/promisemed-hangzhou-meditech