Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Promisemed Hangzhou Meditech Co., Ltd. · Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
244 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261196 | Promisemed VeriEcto Automatic Biopsy Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-12 | 29 | 0 |
| K261045 | Verifine Safety Lancets | Promisemed Hangzhou Meditech Co., Ltd. | 2026-05-01 | 31 | 0 |
| K254273 | Verisafe Safety Sterile Needles (SSN) | Promisemed Hangzhou Meditech Co., Ltd. | 2026-04-16 | 107 | 0 |
| K250192 | Verisafe Safety Retractable Insulin Syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2025-12-10 | 321 | 0 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 | 65 | 0 |
| K251138 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-05-13 | 29 | 0 |
| K243332 | Promisemed Safety Huber Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2025-03-14 | 141 | 0 |
| K243806 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2025-01-10 | 30 | 0 |
| K240675 | Endoscopic Injection Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-10-04 | 207 | 0 |
| K242632 | Verifine® Pen Needles | Promisemed Hangzhou Meditech Co., Ltd. | 2024-09-26 | 23 | 0 |
| K234124 | Single Use Hemoclips | Promisemed Hangzhou Meditech Co., Ltd. | 2024-07-12 | 197 | 0 |
| K231792 | VeriSafe Safety sterile syringes | Promisemed Hangzhou Meditech Co., Ltd. | 2023-09-28 | 100 | 0 |
| K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023-06-08 | 85 | 0 |
| K223453 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2023-03-02 | 106 | 0 |
| K223643 | Verifine® Ease Lancing Device, Verifine® Lancing Device | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-21 | 77 | 0 |
| K222271 | Verisafe Safety sterile needles | Promisemed Hangzhou Meditech Co., Ltd. | 2023-02-15 | 201 | 0 |
| K220129 | Promisemed X-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-09-19 | 244 | 0 |
| K221368 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mi | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-09 | 28 | 0 |
| K221371 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2022-06-08 | 27 | 0 |
| K213683 | Promisemed Fine Biopsy Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-22 | 151 | 0 |
| K213560 | Verifine Safety Syringe with Fixed Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2022-04-05 | 147 | 0 |
| K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | 2021-11-17 | 149 | 0 |
| K211242 | Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hyp | Promisemed Hangzhou Meditech Co., Ltd. | 2021-09-09 | 136 | 0 |
| K210712 | Verifine Mechanical Safety Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021-09-08 | 182 | 0 |
| K210946 | Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Bio | Promisemed Hangzhou Meditech Co., Ltd. | 2021-08-12 | 135 | 0 |
| K210059 | Promisemed Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021-07-21 | 191 | 0 |
| K211293 | Safety Winged Blood Collection Sets | Promisemed Hangzhou Meditech Co., Ltd. | 2021-06-25 | 60 | 0 |
| K210065 | Verifine Safety Type Insulin Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2021-04-22 | 101 | 0 |
| K193273 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021-01-05 | 406 | 0 |
| K202681 | Promisemed Covered Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2020-12-31 | 107 | 0 |
| K202682 | Promisemed Triple Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2020-11-24 | 70 | 0 |
| K193009 | Promisemed Heel Blood Lancet | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-03 | 36 | 0 |
| K192666 | Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mi | Promisemed Hangzhou Meditech Co., Ltd. | 2019-12-02 | 68 | 0 |
| K191853 | Dual-Safety Pen Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2019-09-05 | 57 | 0 |
| K161950 | Common Type Insulin Pen Needle, Safety Type Insulin Pen Need | Promisemed Hangzhou Meditech Co., Ltd. | 2017-05-11 | 300 | 0 |
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