Pentaflush
FDA 510(k) K214080 · Pentaferte Italia S.R.L.
510(k) numberK214080
Submission
- Device name
- Pentaflush
- Applicant
- Pentaferte Italia S.R.L.
Campli Teramo, IT - Received
- December 27, 2021
- Decision date
- July 20, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NGT – Saline, Vascular Access Flush
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.
Other 510(k)s with product code NGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250884 | 0.9 % Sodium Chloride Injection, USP, BD PosiFlush SP SyringeNGT · Traditional | Becton, Dickinson and Company | 12/02/2025SE |
| K233623 | Praxiject SP 0.9% NaClNGT · Traditional | Medxl, Inc. | 02/27/2024SE |
| K231724 | Flush Syringe (Prefilled 0.9% normal saline solution)NGT · Traditional | Spm Medicare Pvt. , Ltd. | 11/09/2023SE |
| K231363 | Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)NGT · Traditional | Hantech Medical Device Co., Ltd. | 09/27/2023SE |
| K230756 | TK Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tiankang Medical Technology Co., Ltd. | 08/12/2023SE |
| K223584 | Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Anhui Tianyang Pharmaceutical Co., Ltd. | 08/12/2023SE |
| K231161 | 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Saline Flush SyringeNGT · Traditional | Becton, Dickinson and Company | 07/21/2023SE |
| K231754 | Praxiject 0.9% NaClNGT · Special | Medxl, Inc. | 07/13/2023SE |
| K213522 | AMSafe Pre-Filled Normal Saline Flush SyringeNGT · Traditional | Amsino International, Inc. | 03/22/2022SE |
| K201286 | 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9%…NGT · Traditional | Nurse Assist, LLC | 08/11/2020SE |
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Questions and answers
When was Pentaflush cleared by the FDA?
Pentaflush (K214080) received a 510(k) decision of Substantially Equivalent on July 20, 2022, 205 days after the submission was received.
What is the product code of K214080?
The FDA product code is NGT – Saline, Vascular Access Flush, a Class II (moderate risk) device regulated under 21 CFR 880.5200.