Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

FIB — Predicate Candidate Screening

35 FDA 510(k) clearances under this product code; the 50 most recent screened below.

78 daysmedian FDA review time
209 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K240164NovaLine SP-C35 Transducer Protector (956007)Bain Medical Equipment (Guangzhou) Co., Ltd.2024-06-281580
K072988NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1Nipro Medical Corporation2008-02-211210
K001971HEMODIALYSIS TUBING SETSOfi Biomedica S.P.A.2001-05-243300
K010264NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTNipro Medical Corp.2001-04-27880
K001465NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTNipro Medical Corp.2000-12-052090
K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSFresenius Medical Care North America2000-12-01250
K000702BORLA TRANSDUCER PROTECTOR & HAEMOTRONIC TRANSDUCER PROTECTOFresenius Medical Care North America2000-06-07980
K983076MEDISYSTEMS TRANSDUCER PROTECTORMedisystems Corp.1998-11-25840
K964337BETTER-BLADDER (BB)Circulatory Technology, Inc.1997-05-232040
K970536MEDISYSTEMS TRANDUCER PROTECTORMedisystems Corp.1997-05-12890
K934069MILLEX, DUALEX (PLUS, ULTRA)Millipore Corp.1994-04-212440
K925978MPC-80 TRANSDUCERMolded Products, Inc.1994-01-144150
K915593TRANSDUCER PROTECTORUnited Pharmaceutical and Medical Supply Co.1992-07-012010
K912394TRANSDUCER PROTECTORFiltertek, Inc.1991-08-30940
K910821TRANSDUCER PROTECTORGelman Sciences, Inc.1991-08-121670
K911658DIALYSIS TRANDSDUCER PROTECTORTico Medical Instruments, Inc.1991-08-121220
K904912TRANSDUCER PROTECTORFiltertek, Inc.1991-01-04650
K902788CLEM TMArbo Medical, Inc.1990-09-12780
K901409TRANSDUCER PROTECTORFiltertek, Inc.1990-07-271230
K901996FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTORFiltertek, Inc.1990-06-01300
K900841HEMODIALYSIS TRANSDUCER PROTECTORMediflex Intl.1990-05-15820
K895856MEDISYSTEMS TRANSDUCER PROTECTORMedisystems Corp.1989-11-24530
K895281TRANSDUCER PROTECTORFiltertek, Inc.1989-11-08760
K891752DA-46 FLUID BARRIERAkcess Medical Products, Inc.1989-04-07150
K870394HYDROPHOBIC #6194418/HYDRAPHILIC #6104418 FILTERSClinical Connections, Inc.1987-03-03320
K863496MEDIFLEX TRANSDUCER PROTECTORMediflex Intl.1986-09-23140
K862015O.2 MICRON INFECTION RESISTANT HYDROPHOBIC FILTERBipore, Inc.1986-07-22550
K851734OMNIMED SUPERIOR TRANSDUCER PROTECTOROmni Intl., Inc.1985-05-23280
K851428TRANDUCER PROTECTORGalvin Industries, Inc.1985-05-21410
K851230GAMBRO PRESSURE MONITOR GUARDSGambro, Inc.1985-04-09140
K821268TRANSDUCER FILTERCp Medical1982-06-23510
K812162HEMODIALYSIS TRANSDUCER PROTECTORMembrana1981-09-24570
K812107RENALAB TRANSDUCER PROTECTOR, .22 MICRONRenalab1981-08-20240
K811859BACTASHIELDTri-Med, Inc.1981-08-07370
K811892CORDIS DOW SERA FLO TM TRANSDUCER PROTCordis Corp.1981-07-31300

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda