Product code FIB
- Device name
- Protector, Transducer, Dialysis
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5820
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240164 | NovaLine SP-C35 Transducer Protector (956007) | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-06-28 |
| K072988 | NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 | Nipro Medical Corporation | 2008-02-21 |
| K001971 | HEMODIALYSIS TUBING SETS | Ofi Biomedica S.P.A. | 2001-05-24 |
| K010264 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | Nipro Medical Corp. | 2001-04-27 |
| K001465 | NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET | Nipro Medical Corp. | 2000-12-05 |
| K003445 | FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 | Fresenius Medical Care North America | 2000-12-01 |
| K000702 | BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR | Fresenius Medical Care North America | 2000-06-07 |
| K983076 | MEDISYSTEMS TRANSDUCER PROTECTOR | Medisystems Corp. | 1998-11-25 |
| K964337 | BETTER-BLADDER (BB) | Circulatory Technology, Inc. | 1997-05-23 |
| K970536 | MEDISYSTEMS TRANDUCER PROTECTOR | Medisystems Corp. | 1997-05-12 |
| K934069 | MILLEX, DUALEX (PLUS, ULTRA) | Millipore Corp. | 1994-04-21 |
| K925978 | MPC-80 TRANSDUCER | Molded Products, Inc. | 1994-01-14 |
| K915593 | TRANSDUCER PROTECTOR | United Pharmaceutical and Medical Supply Co. | 1992-07-01 |
| K912394 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1991-08-30 |
| K910821 | TRANSDUCER PROTECTOR | Gelman Sciences, Inc. | 1991-08-12 |
| K911658 | DIALYSIS TRANDSDUCER PROTECTOR | Tico Medical Instruments, Inc. | 1991-08-12 |
| K904912 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1991-01-04 |
| K902788 | CLEM TM | Arbo Medical, Inc. | 1990-09-12 |
| K901409 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1990-07-27 |
| K901996 | FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR | Filtertek, Inc. | 1990-06-01 |
| K900841 | HEMODIALYSIS TRANSDUCER PROTECTOR | Mediflex Intl. | 1990-05-15 |
| K895856 | MEDISYSTEMS TRANSDUCER PROTECTOR | Medisystems Corp. | 1989-11-24 |
| K895281 | TRANSDUCER PROTECTOR | Filtertek, Inc. | 1989-11-08 |
| K891752 | DA-46 FLUID BARRIER | Akcess Medical Products, Inc. | 1989-04-07 |
| K870394 | HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS | Clinical Connections, Inc. | 1987-03-03 |
| K863496 | MEDIFLEX TRANSDUCER PROTECTOR | Mediflex Intl. | 1986-09-23 |
| K862015 | O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER | Bipore, Inc. | 1986-07-22 |
| K851734 | OMNIMED SUPERIOR TRANSDUCER PROTECTOR | Omni Intl., Inc. | 1985-05-23 |
| K851428 | TRANDUCER PROTECTOR | Galvin Industries, Inc. | 1985-05-21 |
| K851230 | GAMBRO PRESSURE MONITOR GUARDS | Gambro, Inc. | 1985-04-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 16948082770033 | NovaLine | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-07-31 |
| 06948082770036 | NovaLine | Bain Medical Equipment (Guangzhou) Co., Ltd. | 2024-07-31 |
| B144MPC852 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2018-01-04 |
| B144MPC853 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2018-01-04 |
| B144MPC85TE3 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2016-12-16 |
| B144MPC85TE2 | Molded Products, Inc. | MOLDED PRODUCTS, INC. | 2016-12-16 |
| 04054839078217 | Dualex Transducer Protector | MERCK MILLIPORE LIMITED | 2016-09-01 |
| 04054839076756 | Hydromillex | MERCK MILLIPORE LIMITED | 2016-09-01 |
| 04054839076572 | Dualex Ultra Transducer Protector | MERCK MILLIPORE LIMITED | 2016-09-01 |
| 04054839076565 | Dualex Plus Transducer Protector | MERCK MILLIPORE LIMITED | 2016-09-01 |
| 04054839076473 | Millex - FH | MERCK MILLIPORE LIMITED | 2016-09-01 |
| 05034480315106 | Pall | Pall International Sàrl | 2015-10-21 |
| 35034480315107 | Pall | Pall International Sàrl | 2015-10-21 |
| 20840861100549 | Fresenius | Fresenius Medical Care Holdings, Inc. | 2015-09-30 |
| 10840861100542 | Fresenius | Fresenius Medical Care Holdings, Inc. | 2015-09-30 |
| 10383790004500 | NIPRO TP-SURE | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 00383790004503 | NIPRO TP-SURE | NIPRO MEDICAL CORPORATION | 2015-09-16 |
| 04053252725180 | Hydromillex | MERCK MILLIPORE LIMITED | 2015-09-04 |
| 04053252660283 | Dualex Ultra Transducer Protector | MERCK MILLIPORE LIMITED | 2015-09-04 |
| 04053252397837 | Millex - FH | MERCK MILLIPORE LIMITED | 2015-09-04 |
| 08436037123160 | Dualex Transducer Protector | MERCK MILLIPORE LIMITED | 2015-09-04 |
| 04053252398018 | Dualex Plus Transducer Protector | MERCK MILLIPORE LIMITED | 2015-09-01 |
| M535M820062 | ViraGuard Viral Blocking Patient Transducer Protector | MEDISYSTEMS CORPORATION | 2015-09-01 |