TK Safety Needle
FDA 510(k) K191644 · Anhui Tiankang Medical Technology Co., Ltd.
510(k) numberK191644
Submission
- Device name
- TK Safety Needle
- Applicant
- Anhui Tiankang Medical Technology Co., Ltd.
Tianchang, CN - Received
- June 19, 2019
- Decision date
- August 6, 2020
- 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 |
|---|---|---|
| K222773 | Feeding TubePIF · Traditional | 08/17/2023SE |
| K222772 | Oral/Enteral Syringe with ENFit connectorPNR · Traditional | 08/17/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | 08/12/2023SE |
| K222385 | Bifurcated NeedleSCL · Traditional | 12/06/2022SE |
| K220204 | Disposabel Syringe with permanently attached needle, Safety Syringe with permanently…FMF · Traditional | 07/14/2022SE |
| K212368 | Surgical Face MaskFXX · Traditional | 10/24/2021SE |
| K210464 | Auto Disable SyringeFMF · Traditional | 08/24/2021SE |
| K191639 | TK Insulin Syringe with/without Saftey Retractable DeviceMEG · Traditional | 09/11/2020SE |
| K191640 | TK Intravascular Administration SetFPA · Traditional | 08/26/2020SE |
| K191642 | TK Sterile Piston Syringe without NeedleFMF · Traditional | 01/06/2020SE |
Questions and answers
When was TK Safety Needle cleared by the FDA?
TK Safety Needle (K191644) received a 510(k) decision of Substantially Equivalent on August 6, 2020, 414 days after the submission was received.
What is the product code of K191644?
The FDA product code is FMI – Needle, Hypodermic, Single Lumen, a Class II (moderate risk) device regulated under 21 CFR 880.5570.