Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FFX — Predicate Candidate Screening
69 FDA 510(k) clearances under this product code; the 50 most recent screened below.
109 daysmedian FDA review time
401 days90th percentile
69clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252605 | mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) | Medspira, LLC | 2025-12-05 | 109 | 0 |
| K240007 | Solar Compact (G4-1) | Laborie Medical Technologies, Corp. | 2024-05-06 | 125 | 0 |
| K231861 | EndoflipTM 300 System | Covidien, LLC | 2023-07-21 | 28 | 0 |
| K223705 | EndoflipTM 300 | Covidien, LLC | 2023-04-14 | 123 | 0 |
| K222000 | Transit-Pellets | Medifactia AB | 2023-01-18 | 195 | 0 |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | 2020-05-21 | 27 | 0 |
| K191087 | IntraMarX Radiopaque Markers | Anx Robotica Corp | 2019-12-18 | 238 | 0 |
| K190208 | Diversatek Healthcare High Resolution Impedance Manometry (H | Diversatek Healthcare | 2019-10-03 | 241 | 1 |
| K181760 | Transit-Pellets | Medifactia AB | 2019-08-08 | 401 | 0 |
| K183072 | EndoFLIP System | Crospon, Ltd. | 2019-02-15 | 102 | 1 |
| K181750 | SITZMARKS | Konsyl Pharmaceuticals | 2018-11-15 | 136 | 0 |
| K170833 | EndoFLIP® System with FLIP Topography module | Crospon, Ltd. | 2017-04-17 | 28 | 0 |
| K160287 | Rapid Barostat Bag (RBB) Pump and Catheter | Mui Scientific | 2017-03-14 | 405 | 0 |
| K160170 | Lehman Manometry Catheter | Wilson-Cook Medical, Inc. | 2016-06-20 | 145 | 0 |
| K160725 | EndoFLIP | Crospon, Ltd. | 2016-05-01 | 46 | 0 |
| K151086 | ManoScan System | Given Imaging , Ltd. | 2016-04-28 | 372 | 0 |
| K130906 | ENDOFLIP CATHETER | Crospon, Ltd. | 2013-07-17 | 107 | 0 |
| K122294 | PRESSURIZED INFUSION PUMP | Mui Scientific | 2012-11-01 | 93 | 0 |
| K120997 | BAROSTAT SOFTWARE OPTION | Crospon, Ltd. | 2012-08-27 | 147 | 0 |
| K121014 | SOLAR GI | Medical Measurement Systems B.V. | 2012-08-01 | 120 | 1 |
| K120524 | SPHINCTER OF ODDI MANOMETRIC (SOM) SYSTEM | Mui Scientific | 2012-06-21 | 120 | 0 |
| K102214 | ENDO FLIP | Crospon, Ltd. | 2010-12-16 | 132 | 0 |
| K102801 | PHTIP DISPOSABLE ISFET CATHETER | E-Cath Co., Ltd. | 2010-10-26 | 29 | 0 |
| K092850 | ENDOFLIP | Crospon, Ltd. | 2009-12-15 | 90 | 0 |
| K091070 | MANOSCAN MOTILITY WITH IMPEDANCE VISUALIZATION SYSTEM | Sierra Scientific Instruments, Inc. | 2009-05-19 | 35 | 0 |
| K082056 | ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1 | Life-Tech, Inc. | 2008-11-07 | 109 | 0 |
| K071094 | MODIFICATION TO SOLAR GI | Medical Measurement Systems B.V. | 2007-08-13 | 117 | 0 |
| K062222 | UNITIP HIGH RESOLUTION CATHETER | Unisensor AG | 2007-03-15 | 225 | 0 |
| K060166 | OHMEGA | Medical Measurement Systems B.V. | 2006-04-21 | 88 | 0 |
| K052338 | SOLAR GI | Medical Measurement Systems B.V. | 2005-12-15 | 111 | 0 |
| K031084 | SOLAR GI SYSTEM | Medical Measurement Systems B.V. | 2004-03-19 | 350 | 0 |
| K031169 | MOTILITY VISUALIZATION SYSTEM | Sierra Scientific Instruments, Inc. | 2003-12-12 | 242 | 1 |
| K011471 | BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE | Medtronic Functional Diagnostics A/S | 2002-11-08 | 543 | 0 |
| K012232 | INSIGHT, MODEL S980000 | Sandhill Scientific, Inc. | 2002-06-07 | 326 | 2 |
| K013154 | MARK II/MARK III MANOMETRIC PERFUSION PUMP | Dentsleeve Pty., Ltd. | 2001-10-19 | 29 | 0 |
| K011472 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM | Medtronic Functional Diagnostics A/S | 2001-08-10 | 88 | 0 |
| K003580 | UNITIP GASTROINTESTINAL PRESSURE SENSOR CATHETER | Unisensor AG | 2001-07-31 | 253 | 0 |
| K002427 | SANDHILL UNITIP CATHETER PRESSURE SENSOR, MODEL K 5251-L3-00 | Sandhill Scientific, Inc. | 2001-06-22 | 318 | 0 |
| K004040 | REDTECH GIPC 2000 | Red-Tech, Inc. | 2001-03-29 | 90 | 0 |
| K010130 | POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL | Medtronic Functional Diagnostics A/S | 2001-02-07 | 22 | 0 |
| K000386 | POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, MODEL 90 | Medtronic Functional Diagnostics A/S | 2000-05-05 | 88 | 0 |
| K992713 | POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLI | Medtronic Functional Diagnostics A/S | 1999-11-10 | 90 | 0 |
| K991389 | ANORECTAL MANOMETRY SUITE, MODEL 9032S0201 | Medtronic Functional Diagnostics A/S | 1999-07-15 | 85 | 0 |
| K991288 | DISTENDER SERIES II BAROSTAT | G & J Electronics, Inc. | 1999-06-08 | 55 | 0 |
| K973844 | GASTRIC AND RECTAL CATHETERS | G & J Electronics, Inc. | 1999-06-04 | 604 | 0 |
| K990441 | INSIGHT SPHINCTER OF ODDI MANOMETRY MODULE, MODEL S981300 | Sandhill Scientific, Inc. | 1999-05-12 | 90 | 0 |
| K981733 | DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTEN | Medtronic Functional Diagnostics A/S | 1999-02-04 | 262 | 1 |
| K984444 | INSIGHT GASTROINTESTINAL MOTILITY SYSTEM, MODEL S980000 | Sandhill Scientific, Inc. | 1999-01-11 | 28 | 0 |
| K980980 | MOTILITY PROBE MODEL NUMBERS P31 THRU P38, P40 THRU P43 AND | Konigsberg Instruments, Inc. | 1998-06-15 | 90 | 0 |
| K980946 | MARK II CO2 FLUSH MANOMETRIC PERFUSION PUMP & MARK II MANOME | Dentsleeve Pty., Ltd. | 1998-06-08 | 87 | 0 |
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