Transducer Protector
FDA 510(k) K901409 · Filtertek, Inc.
510(k) numberK901409
Submission
- Device name
- Transducer Protector
- Applicant
- Filtertek, Inc.
Hebron, IL, US - Received
- March 26, 1990
- Decision date
- July 27, 1990
- 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 |
|---|---|---|
| K981548 | NFC Needlefree Connector Model 69900FPA · Traditional | 06/18/1998SE |
| K981547 | NFC Needlefree Y-Site, Model 69970FPA · Traditional | 06/18/1998SE |
| K914792 | PN 62290 0.22 Micron Micro Infus I.V. Exten SetFPA · Traditional | 01/15/1992SE |
| K912848 | I.V. Filter Extension SetFPB · Traditional | 11/29/1991SE |
| K912394 | Transducer ProtectorFIB · Traditional | 08/30/1991SE |
| K911451 | I.V. Extender SetFPB · Traditional | 06/06/1991SE |
| K904912 | Transducer ProtectorFIB · Traditional | 01/04/1991SE |
| K901996 | Filtertek PN 60650 Dialysis Transducer ProtectorFIB · Traditional | 06/01/1990SE |
| K895281 | Transducer ProtectorFIB · Traditional | 11/08/1989SE |
Questions and answers
When was Transducer Protector cleared by the FDA?
Transducer Protector (K901409) received a 510(k) decision of Substantially Equivalent on July 27, 1990, 123 days after the submission was received.
What is the product code of K901409?
The FDA product code is FIB – Protector, Transducer, Dialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.