Atlas FDA

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

FEN · Predicate Candidate Screening

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

93 daysmedian FDA review time
269 days90th percentile
36clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K212830CT3000ProSrs Medical2021-12-211050
K082701URONIRS, MODEL 2000Urodynamix Technologies, Ltd.2008-12-18930
K073552LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORYLaborie Medical Technologies, Corp.2008-03-05780
K001386ACCUSET SENSOR, MODEL 2000Pelvicare, Inc.2000-07-17760
K992715NEURO URODYNAMIC SUITE, MODEL 9032E0101Medtronic Functional Diagnostics A/S2000-02-282000
K983325IN-PROBE II URODYNAMIC SYSTEMInfluence, Inc.1998-11-24630
K970595CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMPCircon Video1997-10-242480
K971911LUMAX CYSTOMETRY ADMINISTRATION TUBE SETMedamicus, Inc.1997-06-03360
K964522ELLIPSE 4Andromeda Medizinische Systeme GmbH1997-03-211290
K960503DANTEC DUETDantec Medical, Inc.1996-09-162270
K953734LUMAX(MODIFICATION)Medamicus, Inc.1996-01-181850
K954093LUMAX (MODIFICATION)Medamicus, Inc.1996-01-111550
K954315PVC ABDOMINAL/RECTAL PRESSURE CATHETERLife-Tech Intl., Inc.1995-11-30760
K954341URODYNAMICS TUBING AND INFUSION SETSLife-Tech Intl., Inc.1995-10-17290
K953451UROPUMP TUBE & DAMPING CHAMGERLife-Tech Intl., Inc.1995-10-05790
K953353UROVISION JANUSLife-Tech Intl., Inc.1995-09-08530
K951805PIPER, MODEL NUMBER UDS-PIPERBLaborie Medical Technologies, Ltd.1995-07-06790
K952573RUSCH URODYNAMIC RECTAL BALLOON CATHETERRusch Intl.1995-06-15100
K952029RUSCH INTERNATIONAL URODYNAMIC CATHETERSRusch Intl.1995-06-13430
K945753FST FIBEROPTIC PRESSURE CONVERTERFiberoptic Sensor Technlogies, Inc.1995-05-111690
K950908FST CATH-UD, CATHETERFiberoptic Sensor Technlogies, Inc.1995-04-07500
K950016CART, MODE NUMBER UDS-CARTLaborie Medical Tech Corp.1995-03-30860
K944391OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEMSurgitek1995-02-071510
K942023INFUSION PUMP, MODEL NO. UDP-5Laborie Medical Technologies, Ltd.1994-07-12770
K936041UROGRAM CYSTOMETROGRAMMyo/Kinetic Systems, Inc.1994-04-181190
K940203TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERSLife-Tech Intl., Inc.1994-03-30760
K934141STAND ALONE CYSTOMETROGRAMMedical Engineering Corp.1993-11-18850
K930171FST DUAL, DUAL PRESSURE URODYNAMICS MONITORFiberoptic Sensor Technlogies, Inc.1993-11-042950
K933399KENDALL URODYNAMIC CATHETERSKendall Healthcare Products Co. Div.Of Tyco Health1993-11-021130
K930135SILICONE RECTAL BALLOONCook Urological, Inc.1993-10-082690
K924714BARD URODYNAMIC CATHETERC.R. Bard, Inc.1993-09-213650
K922776FST COUNCIL TIP FOLEY CATHETERFiberoptic Sensor Technlogies, Inc.1993-07-204060
K926088FST CATH UD-DUAL DUAL PRESSURE CATHETERFiberoptic Sensor Technlogies, Inc.1993-06-181980
K913113FST CATH-UD CATHETER, MODIFICATIONFiberoptic Sensor Technlogies, Inc.1991-10-09960
K913721FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEMFiberoptic Sensor Technlogies, Inc.1991-10-08490
K905641FST CATH-UD CATHETERFiberoptic Sensor Technlogies, Inc.1991-02-19630

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