Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KLA — Predicate Candidate Screening
31 FDA 510(k) clearances under this product code; the 50 most recent screened below.
172 daysmedian FDA review time
319 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | 2025-02-12 | 160 | 0 |
| K242304 | RED | Neuraxis, Inc. | 2024-12-06 | 123 | 0 |
| K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L | Laborie Medical Technologies, Corp. | 2024-04-23 | 119 | 0 |
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018-03-08 | 50 | 0 |
| K161785 | THD ANOPRESS | Thd Spa | 2017-03-14 | 258 | 0 |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015-07-07 | 259 | 0 |
| K120088 | MCOMPASS ANORECTAL MANOMETRY SYSTEM | Medspira, LLC | 2012-03-29 | 78 | 0 |
| K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO | Sarmed Srl | 2007-04-13 | 242 | 0 |
| K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | Mediplus , Ltd. | 2004-01-16 | 238 | 0 |
| K032138 | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRON | Medtronic Vascular | 2003-10-09 | 90 | 0 |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPAS | Clinical Innovations, Inc. | 2003-01-07 | 201 | 0 |
| K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | Mediplus , Ltd. | 2002-08-05 | 270 | 0 |
| K983665 | MANOMETRIC ASSEMBLIES | Dentsleeve Pty., Ltd. | 1999-05-17 | 210 | 0 |
| K964804 | FLEXILOG LS | Oakfield Instruments, Ltd. | 1997-08-06 | 250 | 0 |
| K964589 | FLEXILOG 3000 | Oakfield Instruments, Ltd. | 1997-03-04 | 109 | 0 |
| K961895 | FLEXILOG LS 13921 | Oakfield Instruments, Ltd. | 1996-11-04 | 172 | 0 |
| K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | Synectics Medical, Inc. | 1996-06-11 | 85 | 0 |
| K961056 | BIOVIEW MODEL S960000 | Sandhill Scientific, Inc. | 1996-06-06 | 80 | 0 |
| K954798 | 7100 SWALLOWING WORKSTATION | Kay Elemetrics Corp. | 1996-06-04 | 230 | 0 |
| K941801 | ANALGRAPH | Sandhill Scientific, Inc. | 1995-09-08 | 514 | 0 |
| K922553 | CLA-COMPUTERIZED LARYNGEAL ANALYZER | H.I.L. Research, Ltd. | 1994-08-23 | 816 | 0 |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | Synectics-Dantec | 1993-12-13 | 840 | 0 |
| K901125 | PROVOCATIVE SENSITIVITY BALLOON | Wilson-Cook Medical, Inc. | 1991-01-25 | 319 | 0 |
| K900239 | WILSON-COOK ESOPHAGEAL MOTILITY CATHETER | Wilson-Cook Medical, Inc. | 1990-07-16 | 180 | 0 |
| K884527 | ZINETICS(R) EMC | Zinetics Medical, Inc. | 1989-02-28 | 124 | 0 |
| K882551 | AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 | Intl. Biomedics, Inc. | 1988-10-12 | 113 | 0 |
| K872712 | PC POLYGRAF | Synectics-Dantec | 1988-03-18 | 252 | 0 |
| K821588 | SANDHILL DMS | Sandhill | 1982-06-22 | 21 | 0 |
| K771723 | HILL TUBE | Physio-Control Corp. | 1977-11-22 | 70 | 0 |
| K771265 | PRESSURE MONITOR MANOMETRIC SYS. | Physio-Control Corp. | 1977-11-22 | 132 | 0 |
| K770785 | MONITOR, RESPIRATORY, TWO-GAS, RDC | Research Development Corp. | 1977-05-20 | 18 | 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