Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (K252033)
Description
Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle by Cmt Health Pte., Ltd., an FDA 510(k) cleared general hospital device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K252033
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. Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (K252033) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K211211 | Sterile syringes for single use with/without needle | Azur Medical Company, Inc. | 2021 |
Trace the full predicate network for K252033
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.