Mediflex Transducer Protector
FDA 510(k) K863496 · Mediflex Intl.
510(k) numberK863496
Submission
- Device name
- Mediflex Transducer Protector
- Applicant
- Mediflex Intl.
Pine Brook, NJ, US - Received
- September 9, 1986
- Decision date
- September 23, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K915140 | Primary Dressing TrayLYY · Traditional | 02/11/1992SEKD |
| K900841 | Hemodialysis Transducer ProtectorFIB · Traditional | 05/15/1990SE |
| K891077 | Mediverse Parenteral Nutrition BagKPE · Traditional | 05/24/1989SE |
| K884243 | Blood Tubing SetFJK · Traditional | 12/08/1988SE |
| K855039 | Mediflex Injection CapGCE · Traditional | 01/24/1986SE |
| K854346 | Mediflex Disposable Tubing ClampFPA · Traditional | 11/18/1985SE |
| K852106 | I.V. Administration SetFPA · Traditional | 06/07/1985SE |
| K843126 | Mediflex Drainage BagKNX · Traditional | 10/04/1984SE |
Questions and answers
When was Mediflex Transducer Protector cleared by the FDA?
Mediflex Transducer Protector (K863496) received a 510(k) decision of Substantially Equivalent on September 23, 1986, 14 days after the submission was received.
What is the product code of K863496?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.