Atlas FDA

FEN

36 FDA 510(k) clearances · Product code

93 daysmedian time to decision
269 days90th percentile
36clearances measured

FDA profile

Official device name
Device, Cystometric, Hydraulic
Device class
Class II (moderate risk)
Regulation
21 CFR 876.1620
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2005: 17 · 2006: 3 · 2013: 10 · 2014: 11 · 2015: 33 · 2016: 10
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
CT3000Pro (K212830)Srs Medical2021-12-21
URONIRS, MODEL 2000 (K082701)Urodynamix Technologies, Ltd.2008-12-18
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY (K073552)Laborie Medical Technologies, Corp.2008-03-05
ACCUSET SENSOR, MODEL 2000 (K001386)Pelvicare, Inc.2000-07-17
NEURO URODYNAMIC SUITE, MODEL 9032E0101 (K992715)Medtronic Functional Diagnostics A/S2000-02-28
IN-PROBE II URODYNAMIC SYSTEM (K983325)Influence, Inc.1998-11-24
CIRCON ENDOTEK OM-4 H2O CYSTOMETRY PUMP (K970595)Circon Video1997-10-24
LUMAX CYSTOMETRY ADMINISTRATION TUBE SET (K971911)Medamicus, Inc.1997-06-03
ELLIPSE 4 (K964522)Andromeda Medizinische Systeme GmbH1997-03-21
DANTEC DUET (K960503)Dantec Medical, Inc.1996-09-16
LUMAX(MODIFICATION) (K953734)Medamicus, Inc.1996-01-18
LUMAX (MODIFICATION) (K954093)Medamicus, Inc.1996-01-11
PVC ABDOMINAL/RECTAL PRESSURE CATHETER (K954315)Life-Tech Intl., Inc.1995-11-30
URODYNAMICS TUBING AND INFUSION SETS (K954341)Life-Tech Intl., Inc.1995-10-17
UROPUMP TUBE & DAMPING CHAMGER (K953451)Life-Tech Intl., Inc.1995-10-05
UROVISION JANUS (K953353)Life-Tech Intl., Inc.1995-09-08
PIPER, MODEL NUMBER UDS-PIPERB (K951805)Laborie Medical Technologies, Ltd.1995-07-06
RUSCH URODYNAMIC RECTAL BALLOON CATHETER (K952573)Rusch Intl.1995-06-15
RUSCH INTERNATIONAL URODYNAMIC CATHETERS (K952029)Rusch Intl.1995-06-13
FST FIBEROPTIC PRESSURE CONVERTER (K945753)Fiberoptic Sensor Technlogies, Inc.1995-05-11
FST CATH-UD, CATHETER (K950908)Fiberoptic Sensor Technlogies, Inc.1995-04-07
CART, MODE NUMBER UDS-CART (K950016)Laborie Medical Tech Corp.1995-03-30
OM-4 (TENATIVE) URODYNAMIC MEASRUEMENT SYSTEM (K944391)Surgitek1995-02-07
INFUSION PUMP, MODEL NO. UDP-5 (K942023)Laborie Medical Technologies, Ltd.1994-07-12
UROGRAM CYSTOMETROGRAM (K936041)Myo/Kinetic Systems, Inc.1994-04-18
TRIPLE LUMEN URODYNAMIC CATHETER WITH RADIOPAQUE MARKERS (K940203)Life-Tech Intl., Inc.1994-03-30
STAND ALONE CYSTOMETROGRAM (K934141)Medical Engineering Corp.1993-11-18
FST DUAL, DUAL PRESSURE URODYNAMICS MONITOR (K930171)Fiberoptic Sensor Technlogies, Inc.1993-11-04
KENDALL URODYNAMIC CATHETERS (K933399)Kendall Healthcare Products Co. Div.Of Tyco Health1993-11-02
SILICONE RECTAL BALLOON (K930135)Cook Urological, Inc.1993-10-08
BARD URODYNAMIC CATHETER (K924714)C.R. Bard, Inc.1993-09-21
FST COUNCIL TIP FOLEY CATHETER (K922776)Fiberoptic Sensor Technlogies, Inc.1993-07-20
FST CATH UD-DUAL DUAL PRESSURE CATHETER (K926088)Fiberoptic Sensor Technlogies, Inc.1993-06-18
FST CATH-UD CATHETER, MODIFICATION (K913113)Fiberoptic Sensor Technlogies, Inc.1991-10-09
FST CATH - UI USRODYNAMIC CATH INTRODUCER SYSTEM (K913721)Fiberoptic Sensor Technlogies, Inc.1991-10-08
FST CATH-UD CATHETER (K905641)Fiberoptic Sensor Technlogies, Inc.1991-02-19

Track FEN automatically

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