Pressone
FDA 510(k) K253047 · Nipro Medical Corporation
510(k) numberK253047
Submission
- Device name
- Pressone
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- September 22, 2025
- Decision date
- March 24, 2026
- 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 |
| K253622 | Safety Pen NeedleFMI · Traditional | Ningbo Medsun Medical Co., Ltd. | 03/18/2026SE |
| K252886 | Pen NeedleFMI · Traditional | Hh Global Technology, Inc. | 01/06/2026SE |
More from Hh Global Technology, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261399 | Elisio-HxQAX · Traditional | 07/28/2026SE |
| K260533 | Elisio-HKDI · Special | 03/19/2026SE |
| K222852 | Nipro SafeTouch Needle; Nipro Syringe with SafeTouch NeedleFMI · Traditional | 05/25/2023SE |
| K212677 | aboNT SYRINGEFMF · Traditional | 04/15/2022SE |
| K190037 | Cronus HP PTA Balloon CatheterLIT · Traditional | 10/24/2019SE |
| K191359 | Nipro SyringeFMF · Traditional | 10/09/2019SE |
| K182940 | Surdial DX Hemodialysis SystemKDI · Traditional | 07/19/2019SE |
| K173029 | Nipro SyringeFMF · Traditional | 03/30/2018SE |
| K161681 | Nipro SafeTouch IV CatheterFOZ · Traditional | 03/08/2017SE |
| K160444 | FB-U HemodialyzerKDI · Traditional | 02/08/2017SE |
Questions and answers
When was Pressone cleared by the FDA?
Pressone (K253047) received a 510(k) decision of Substantially Equivalent on March 24, 2026, 183 days after the submission was received.
What is the product code of K253047?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.