NovaLine SP-C35 Transducer Protector (956007)
FDA 510(k) K240164 · Bain Medical Equipment (Guangzhou) Co., Ltd.
510(k) numberK240164
Submission
- Device name
- NovaLine SP-C35 Transducer Protector (956007)
- Applicant
- Bain Medical Equipment (Guangzhou) Co., Ltd.
Guangzhou, CN - Received
- January 22, 2024
- Decision date
- June 28, 2024
- 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
Other 510(k)s with product code FIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K072988 | Nipro Transducer Protector Tp-Sure, Model TPSURE+1FIB · Traditional | Nipro Medical Corporation | 02/21/2008SE |
| 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 |
More from Millipore Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K252423 | NovaLine Tubing Set for Hemodialysis (BL 124)FJK · Traditional | 05/15/2026SE |
| K213015 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | 04/08/2022SE |
| K201866 | NovaLine Tubing Sets for HemodialysisFJK · Traditional | 03/10/2021SE |
| K203524 | Surgical MasksFXX · Traditional | 02/25/2021SE |
| K163025 | DORA Disposable A.V. Fistula Needle SetsFIE · Traditional | 07/20/2017SE |
| K161582 | DORA Tubing Sets for HemodialysisFJK · Traditional | 06/16/2017SE |
Questions and answers
When was NovaLine SP-C35 Transducer Protector (956007) cleared by the FDA?
NovaLine SP-C35 Transducer Protector (956007) (K240164) received a 510(k) decision of Substantially Equivalent on June 28, 2024, 158 days after the submission was received.
What is the product code of K240164?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.