Promisemed Hangzhou Meditech Co., Ltd.: FDA filings under this applicant name
FDA lists 36 510(k) clearances under the applicant name “Promisemed Hangzhou Meditech Co., Ltd.” (first 2017, latest 2026), across 10 product codes in 4 review panels. Median 510(k) review time under this name: 104 days. Since 2017 the median was 104 days, against 145 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 300 |
| 2018 | 0 | — |
| 2019 | 3 | 57 |
| 2020 | 2 | 88 |
| 2021 | 8 | 142 |
| 2022 | 5 | 147 |
| 2023 | 5 | 100 |
| 2024 | 3 | 197 |
| 2025 | 5 | 65 |
| 2026 | 4 | 61 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Promisemed Hangzhou Meditech Co., Ltd. took a median 104 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 145 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMI | Needle, Hypodermic, Single Lumen | 13 | 13 |
| FMF | Syringe, Piston | 7 | 7 |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 5 | 5 |
| KNW | Instrument, Biopsy | 3 | 3 |
| PTI | Non-Coring (Huber) Needle | 3 | 3 |
| FBK | Endoscopic Injection Needle, Gastroenterology-Urology | 1 | 1 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 1 | 1 |
| MMK | Container, Sharps | 1 | 1 |
| PKL | Hemostatic Metal Clip For The Gi Tract | 1 | 1 |
| QRL | Multiple Use Blood Lancet For Single Patient Use Only | 1 | 1 |
Review panels
- General Hospital (24)
- General and Plastic Surgery (9)
- Gastroenterology and Urology (2)
- Clinical Chemistry (1)
Most recent Promisemed Hangzhou Meditech Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261719 | Promisemed X-Safety Pen Needle | FMI | 2026-08-25 | 91 |
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | KNW | 2026-05-12 | 29 |
| K261045 | Verifine Safety Lancets | FMK | 2026-05-01 | 31 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | FMI | 2026-04-16 | 107 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | FMF | 2025-12-10 | 321 |
| K250961 | Blood collection tube holders | JKA | 2025-06-04 | 65 |
| K251138 | Promisemed Safety Huber Needles | PTI | 2025-05-13 | 29 |
| K243332 | Promisemed Safety Huber Needles | PTI | 2025-03-14 | 141 |
| K243806 | Safety Winged Blood Collection Sets | FMI | 2025-01-10 | 30 |
| K240675 | Endoscopic Injection Needles | FBK | 2024-10-04 | 207 |
26 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Promisemed Hangzhou Meditech Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Promisemed Hangzhou Meditech Co., Ltd.?
FDA lists 36 510(k) clearances under the applicant name “Promisemed Hangzhou Meditech Co., Ltd.” (first 2017, latest 2026), across 10 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Promisemed Hangzhou Meditech Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Promisemed Hangzhou Meditech Co., Ltd. is 104 days. Since 2017: 104 days, versus 145 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Promisemed Hangzhou Meditech Co., Ltd.?
The most frequent FDA product codes under this applicant name are FMI (Needle, Hypodermic, Single Lumen, 13); FMF (Syringe, Piston, 7); FMK (Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature, 5).
Next steps
- See all 36 Promisemed Hangzhou Meditech Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code FMI, Promisemed Hangzhou Meditech Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.