Atlas FDA

FIB

35 FDA 510(k) clearances · Product code

78 daysmedian time to decision
209 days90th percentile
35clearances measured

FDA profile

Official device name
Protector, Transducer, Dialysis
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Adverse events (MAUDE)
1994: 3 · 1995: 20 · 1996: 5 · 2003: 1 · 2004: 4 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
NovaLine SP-C35 Transducer Protector (956007) (K240164)Bain Medical Equipment (Guangzhou) Co., Ltd.2024-06-28
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1 (K072988)Nipro Medical Corporation2008-02-21
HEMODIALYSIS TUBING SETS (K001971)Ofi Biomedica S.P.A.2001-05-24
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET (K010264)Nipro Medical Corp.2001-04-27
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET (K001465)Nipro Medical Corp.2000-12-05
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2 (K003445)Fresenius Medical Care North America2000-12-01
BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOR (K000702)Fresenius Medical Care North America2000-06-07
MEDISYSTEMS TRANSDUCER PROTECTOR (K983076)Medisystems Corp.1998-11-25
BETTER-BLADDER (BB) (K964337)Circulatory Technology, Inc.1997-05-23
MEDISYSTEMS TRANDUCER PROTECTOR (K970536)Medisystems Corp.1997-05-12
MILLEX, DUALEX (PLUS, ULTRA) (K934069)Millipore Corp.1994-04-21
MPC-80 TRANSDUCER (K925978)Molded Products, Inc.1994-01-14
TRANSDUCER PROTECTOR (K915593)United Pharmaceutical and Medical Supply Co.1992-07-01
TRANSDUCER PROTECTOR (K912394)Filtertek, Inc.1991-08-30
TRANSDUCER PROTECTOR (K910821)Gelman Sciences, Inc.1991-08-12
DIALYSIS TRANDSDUCER PROTECTOR (K911658)Tico Medical Instruments, Inc.1991-08-12
TRANSDUCER PROTECTOR (K904912)Filtertek, Inc.1991-01-04
CLEM TM (K902788)Arbo Medical, Inc.1990-09-12
TRANSDUCER PROTECTOR (K901409)Filtertek, Inc.1990-07-27
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR (K901996)Filtertek, Inc.1990-06-01
HEMODIALYSIS TRANSDUCER PROTECTOR (K900841)Mediflex Intl.1990-05-15
MEDISYSTEMS TRANSDUCER PROTECTOR (K895856)Medisystems Corp.1989-11-24
TRANSDUCER PROTECTOR (K895281)Filtertek, Inc.1989-11-08
DA-46 FLUID BARRIER (K891752)Akcess Medical Products, Inc.1989-04-07
HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERS (K870394)Clinical Connections, Inc.1987-03-03
MEDIFLEX TRANSDUCER PROTECTOR (K863496)Mediflex Intl.1986-09-23
O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTER (K862015)Bipore, Inc.1986-07-22
OMNIMED SUPERIOR TRANSDUCER PROTECTOR (K851734)Omni Intl., Inc.1985-05-23
TRANDUCER PROTECTOR (K851428)Galvin Industries, Inc.1985-05-21
GAMBRO PRESSURE MONITOR GUARDS (K851230)Gambro, Inc.1985-04-09
TRANSDUCER FILTER (K821268)Cp Medical1982-06-23
HEMODIALYSIS TRANSDUCER PROTECTOR (K812162)Membrana1981-09-24
RENALAB TRANSDUCER PROTECTOR, .22 MICRON (K812107)Renalab1981-08-20
BACTASHIELD (K811859)Tri-Med, Inc.1981-08-07
CORDIS DOW SERA FLO TM TRANSDUCER PROT (K811892)Cordis Corp.1981-07-31

Track FIB automatically

Every clearance here is in the API, with alerts when new ones post.