Nipro Transducer Protector Tp-Sure, Model TPSURE+1
FDA 510(k) K072988 · Nipro Medical Corporation
510(k) numberK072988
Submission
- Device name
- Nipro Transducer Protector Tp-Sure, Model TPSURE+1
- Applicant
- Nipro Medical Corporation
Miami, FL, US - Received
- October 23, 2007
- Decision date
- February 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FIB – Protector, Transducer, Dialysis
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5820
- Specialty
- Gastroenterology, Urology
- Life-sustaining
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/28/2024SE |
| K001971 | Hemodialysis Tubing SetsFIB · Traditional | Ofi Biomedica S.P.A. | 05/24/2001SE |
| K010264 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 04/27/2001SE |
| K001465 | Nipro Blood Tubing Set for Hemodialysis with Transducer Protectors and Priming SetFIB · Traditional | Nipro Medical Corp. | 12/05/2000SE |
| K003445 | Fresenius Viral Blocking Transducer Protector for Hemodialysis, Model 04-9500-2FIB · Special | Fresenius Medical Care North America | 12/01/2000SE |
| K000702 | Borla Transducer Protector & Haemotronic Transducer ProtectorFIB · Traditional | Fresenius Medical Care North America | 06/07/2000SE |
| K983076 | Medisystems Transducer ProtectorFIB · Traditional | Medisystems Corp. | 11/25/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | Circulatory Technology, Inc. | 05/23/1997SE |
| K970536 | Medisystems Tranducer ProtectorFIB · Traditional | Medisystems Corp. | 05/12/1997SE |
| K934069 | Millex, Dualex (Plus, Ultra)FIB · Traditional | Millipore Corp. | 04/21/1994SE |
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| 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 |
Questions and answers
When was Nipro Transducer Protector Tp-Sure, Model TPSURE+1 cleared by the FDA?
Nipro Transducer Protector Tp-Sure, Model TPSURE+1 (K072988) received a 510(k) decision of Substantially Equivalent on February 21, 2008, 121 days after the submission was received.
What is the product code of K072988?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.