Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
HIG — Predicate Candidate Screening
57 FDA 510(k) clearances under this product code; the 50 most recent screened below.
178 daysmedian FDA review time
602 days90th percentile
57clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261706 | Endomat Select (UP220) | KARL STORZ SE & CO. KG | 2026-07-16 | 55 | 0 |
| K251273 | Asurys Fluid Management System | Boston Scientific Corporation | 2026-03-27 | 337 | 0 |
| K240886 | Fluent Pro Fluid Management System (FLT-200); Fluent Pro Flu | Hologic, Inc. | 2024-07-25 | 115 | 0 |
| K210628 | X-FLO Fluid Management System | Thermedx, LLC | 2021-11-04 | 247 | 0 |
| K201355 | Endomat Select, IBS Shaver Software, License | Karl Storz SE & CO. KG | 2020-07-22 | 62 | 0 |
| K180735 | Endomat Select | Karl Storz SE & CO. KG | 2018-10-31 | 223 | 0 |
| K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018-08-03 | 126 | 0 |
| K173489 | GYN-Pump PH304 | W.O.M. World of Medicine GmbH | 2018-03-28 | 135 | 0 |
| K172040 | Aquilex Fluid Control System AQL-100S | W.O.M. World of Medicine GmbH | 2018-02-05 | 215 | 1 |
| K172048 | FluidSmart | Thermedx, LLC | 2017-09-05 | 61 | 1 |
| K133799 | THERMEDX FLUID MANAGMENT SYSTEM | Thermedx, LLC | 2014-06-20 | 189 | 2 |
| K123732 | HYSTEROSCOPY PUMP HM6 | W.O.M. World of Medicine AG | 2013-04-04 | 120 | 0 |
| K112642 | AQUILEX FLUID CONTROL SYSTEM H112 | W.O.M. World of Medicine AG | 2012-02-06 | 147 | 0 |
| K110852 | DOLPHIN 3 FLUID MANAGEMENT SYSTEM | Gyrus Acmi, Inc. | 2011-07-19 | 113 | 0 |
| K091939 | THERMEDX PRODIGY FLUID MANAGEMENT SYSTEM, MODELS P1000, P200 | Thermedx, LLC | 2010-07-23 | 388 | 2 |
| K031616 | IUR FLUID MANAGEMENT SYSTEM | W.O.M. World of Medicine AG | 2003-08-13 | 82 | 0 |
| K031213 | AQUASENS FLUID MONITORING SYSTEM | Davol, Inc. | 2003-04-30 | 13 | 0 |
| K022449 | HYSTEREOSCOPY PUMP HM4 | W.O.M. World of Medicine AG | 2003-04-10 | 258 | 0 |
| K011876 | DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2 | Circon Video | 2002-01-08 | 207 | 0 |
| K011069 | AQUASENS FLUID MONITORING SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 2001-08-16 | 129 | 0 |
| K000806 | KARL STORZ HYSTEROMAT II | KARL STORZ Endoscopy-America, Inc. | 2000-11-30 | 262 | 0 |
| K991799 | DAVOL HYSTEROSCOPY POUCH DRAPE AND TUBING SET, MODEL OOXXXXO | Davol Inc., Sub. C. R. Bard, Inc. | 1999-09-13 | 110 | 0 |
| K982867 | HYDROFLEX HD HYSTEROSCOPIC DISTENTION SYSTEM,MODEL #'S 00253 | Davol Inc., Sub. C. R. Bard, Inc. | 1999-02-19 | 189 | 0 |
| K983889 | HYS-SURGIFLATOR 150P | W.O.M. World of Medicine GmbH | 1999-01-14 | 73 | 0 |
| K970078 | HYDROFLOEX HD HYSTEROSCOPIC DISTENTION SYSTEM | Davol Inc., Sub. C. R. Bard, Inc. | 1997-12-11 | 336 | 0 |
| K971492 | AUTOMATIC ELECTRONIC HYSTEROSCOPIC INSUFFLATOR | Bei Medical Systems Co., Inc. | 1997-09-05 | 134 | 0 |
| K964136 | HYSTERO CO2-PNEU 2221 | Richard Wolf Medical Instruments Corp. | 1997-01-10 | 87 | 0 |
| K961091 | KARL STORZ MODEL 203020 20 EQUIMAT | KARL STORZ Endoscopy-America, Inc. | 1996-10-03 | 198 | 0 |
| K934866 | HYS-SURGIMAT | W.O.M. World of Medicine GmbH | 1995-10-20 | 738 | 0 |
| K933847 | HYS-SURGIFLATOR VP | W.O.M. World of Medicine GmbH | 1995-08-15 | 739 | 0 |
| K950961 | KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP | KARL STORZ Endoscopy-America, Inc. | 1995-05-25 | 84 | 0 |
| K941743 | CABOT MEDICAL NIAGARA FLUID MANAGEMENT PUMP | Cabot Medical Corp. | 1995-04-19 | 377 | 0 |
| K924523 | HYS-SURGIFLATOR | W.O.M. World of Medicine GmbH | 1995-04-11 | 945 | 0 |
| K936231 | THE KARL STORZ HAMOU ENDOMAT | Karl Storz Endoscopy | 1995-01-24 | 391 | 0 |
| K933384 | BARD HYSTERO-FLO II PUMP | Davol Inc., Sub. C. R. Bard, Inc. | 1994-12-30 | 536 | 0 |
| K933873 | CONCEPT UNIVERSAL PUMP SYSTEM | Linvatec Corp. | 1994-12-29 | 507 | 0 |
| K921871 | HYSTEROMAT(TM) 3700 | F.M. Wiest USA, Inc. | 1994-12-15 | 969 | 0 |
| K930912 | HYSTEROMED 100 | Northgate Technologies, Inc. | 1994-10-17 | 602 | 0 |
| K922632 | WOM HYSTEROFLATOR OP | W.O.M. GmbH | 1994-03-25 | 751 | 0 |
| K931606 | 7-510-25 HYSTEROMED TUBING KIT | Nortech | 1994-01-24 | 298 | 0 |
| K922197 | INSUFFLATOR TUBING KIT | O.R. Concepts, Inc. | 1993-09-24 | 501 | 0 |
| K912498 | THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR | KARL STORZ Endoscopy-America, Inc. | 1991-12-18 | 196 | 0 |
| K911844 | HYSTEROFLATOR 1500 | F.M. Wiest USA, Inc. | 1991-11-21 | 210 | 0 |
| K912789 | LM-100/200LOW FLOW INSUFFLATOR | Leisegang Medical, Inc. | 1991-09-20 | 87 | 0 |
| K905495 | HYSTEROMAT HYSTEROFLATOR HYSTEROSCOPIC INSUFFLATOR | Frigitronics, Inc. | 1991-04-29 | 143 | 0 |
| K905706 | GYN-1500 HYSTEROSCOPIC INUFFLATOR | Circon Acmi | 1991-02-28 | 66 | 0 |
| K901288 | DAVOL SCOPE IRRIGATION SYSTEM | C.R. Bard, Inc. | 1990-10-10 | 204 | 0 |
| K900908 | CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 | Zimmer, Inc. | 1990-05-21 | 83 | 0 |
| K894259 | REGISTER, A DISPOSABLE HYSTEROGRAPHY CUPULA | Washington Regulatory Services | 1990-03-05 | 258 | 0 |
| K895659 | HUI MINI-FLEX | Unimar, Inc. | 1989-12-19 | 90 | 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