U&U Blood Collection Sets
FDA 510(k) K181508 · U&U Medical Technology Co, Ltd.
510(k) numberK181508
Submission
- Device name
- U&U Blood Collection Sets
- Applicant
- U&U Medical Technology Co, Ltd.
Changzhou, CN - Received
- June 7, 2018
- Decision date
- February 13, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FMI – Needle, Hypodermic, Single Lumen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5570
- Specialty
- General Hospital
Other 510(k)s with product code FMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261719 | Promisemed X-Safety Pen NeedleFMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 08/25/2026SE |
| K262427 | Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety…FMI · Special | Hh Global Technology, Inc. | 08/10/2026SE |
| K260933 | Safety Sterile Hypodermic Needles (NR-S1816R, NR-S1916R, NR-S1925R, NR-S1938R…FMI · Traditional | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 08/07/2026SE |
| K261829 | Profoject Dual-Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 07/29/2026SE |
| K260739 | Profoject Pen Needles (Model A; Model B)FMI · Traditional | CMT Health PTE., Ltd. | 07/15/2026SE |
| K260855 | Profoject Safety Pen NeedlesFMI · Traditional | CMT Health PTE., Ltd. | 06/10/2026SE |
| K254273 | Verisafe Safety Sterile Needles (SSN)FMI · Special | Promisemed Hangzhou Meditech Co., Ltd. | 04/16/2026SE |
| K252908 | Easydrip Classic Pen Needle; Easydrip Plus Pen Needle; Easydrip Classic Pro Pen Needle…FMI · Special | Sandstone Medical (Suzhou), Inc. | 03/25/2026SE |
| K253047 | PressoneFMI · Traditional | Nipro Medical Corporation | 03/24/2026SE |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
More from Ningbo Medsun Medical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K171823 | U&U Indicator tape and stripJOJ · Traditional | 02/22/2018SE |
| K160855 | U&U Enteral SyringePNR · Traditional | 11/22/2016SE |
| K152808 | U&U Insulin Syringe with/without Safety Retractable DeviceMEG · Traditional | 03/25/2016SE |
| K151151 | U & U Intravascular Administration SetFPA · Traditional | 09/24/2015SE |
| K143637 | U&U Sterilization Pouch and RollFRG · Traditional | 09/09/2015SE |
| K143629 | U&U Bowie-Dick Test PackJOJ · Traditional | 05/19/2015SE |
| K132553 | U&U Sterile Piston Syringe Without NeedleFMF · Traditional | 02/27/2014SE |
| K123162 | U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollFRG · Traditional | 02/26/2014SE |
| K132552 | U&U Sterile Hypodermic NeedleFMI · Traditional | 11/13/2013SE |
Questions and answers
When was U&U Blood Collection Sets cleared by the FDA?
U&U Blood Collection Sets (K181508) received a 510(k) decision of Substantially Equivalent on February 13, 2019, 251 days after the submission was received.
What is the product code of K181508?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.