O.2 Micron Infection Resistant Hydrophobic Filter
FDA 510(k) K862015 · Bipore, Inc.
510(k) numberK862015
Submission
- Device name
- O.2 Micron Infection Resistant Hydrophobic Filter
- Applicant
- Bipore, Inc.
Demarest, NJ, US - Received
- May 28, 1986
- Decision date
- July 22, 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 |
|---|---|---|
| K073434 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Special | 04/01/2008SE |
| K073318 | Bipore Balloon Dilation CatheterLIT · Special | 01/16/2008SE |
| K051513 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Abbreviated | 12/07/2005SE |
| K041293 | Biopore Balloon Dilation CatheterLIT · Abbreviated | 07/09/2004SE |
| K983650 | Bipore Balloon Dilatation CatheterLIT · Traditional | 02/17/1999SE |
| K973563 | Bipore Balloon Dilatation CatheterLIT · Traditional | 04/01/1998SE |
| K964814 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Traditional | 05/07/1997SE |
| K961980 | Bipore Balloon Dilatation CatheterLIT · Traditional | 09/12/1996SE |
| K844625 | Bipore O.2 Micron Hydrophobic Filter AssemblyKOZ · Traditional | 01/16/1985SE |
Questions and answers
When was O.2 Micron Infection Resistant Hydrophobic Filter cleared by the FDA?
O.2 Micron Infection Resistant Hydrophobic Filter (K862015) received a 510(k) decision of Substantially Equivalent on July 22, 1986, 55 days after the submission was received.
What is the product code of K862015?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.