MPC-80 Transducer
FDA 510(k) K925978 · Molded Products, Inc.
510(k) numberK925978
Submission
- Device name
- MPC-80 Transducer
- Applicant
- Molded Products, Inc.
Harlan, IA, US - Received
- November 25, 1992
- Decision date
- January 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007)FIB · Traditional | Bain Medical Equipment (Guangzhou) Co., Ltd. | 06/28/2024SE |
| 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 |
More from Medisystems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K022068 | Tubing, Dialysate (and Connector)FID · Traditional | 09/23/2002SE |
| K010366 | Disposable Storage CapFJI · Abbreviated | 11/28/2001SE |
| K010712 | Dialysate Line with Connectors/Re-Use Wash-Out LinesFID · Abbreviated | 09/27/2001SE |
| K003712 | Modification to Male to Male Luer AdapterKOC · Traditional | 05/16/2001SE |
| K925930 | MPC-150 Male to Male Luer AdapterFPA · Traditional | 08/16/1993SE |
| K925927 | MPC-1000 Injection Cap/PlugFPA · Traditional | 08/16/1993SE |
Questions and answers
When was MPC-80 Transducer cleared by the FDA?
MPC-80 Transducer (K925978) received a 510(k) decision of Substantially Equivalent on January 14, 1994, 415 days after the submission was received.
What is the product code of K925978?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.