Class Class II
Insulin Syringe (K223453)
Description
Insulin Syringe by Promisemed Hangzhou Meditech Co., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK223453
Clearance Date2023-03-02
Clearance TypeTraditional
Product CodeFMF
Regulation Number880.5860
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223453
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Insulin Syringe (K223453) cites 2 predicate devices and is itself cited by 2 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K193273 | Insulin Syringe | Promisemed Hangzhou Meditech Co., Ltd. | 2021 |
| K110421 | DISPOSABLE INSULIN SYRINGE | Wenzhou Wuzhou Import & Export Co.,... | 2011 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K253068 | Profoject™ Insulin Syringes; Profoject™ Safelock Disposable... | CMT Health PTE., Ltd. | 2026 |
| K233794 | Insulin Syringe | Spm Medicare Pvt. , Ltd. | 2024 |
Trace the full predicate network for K223453
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.