Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
JIL — Predicate Candidate Screening
81 FDA 510(k) clearances under this product code; the 50 most recent screened below.
106 daysmedian FDA review time
273 days90th percentile
81clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K193514 | AUTION MAX AX-4060 Urinalysis System | Arkray, Inc. | 2023-04-13 | 1211 | 0 |
| K183432 | cobas u 601 urinalysis test system | Roche Diagnostics | 2019-05-07 | 147 | 0 |
| K173327 | DIP/U.S. Urine Analysis Test System | Healthy.Io, Ltd. | 2018-07-18 | 271 | 0 |
| K180356 | inui In-Home Urine Analysis Test System | Scanadu, Inc. | 2018-05-25 | 106 | 0 |
| K181024 | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent | DFI Co., Ltd. | 2018-05-23 | 35 | 0 |
| K171521 | DUS R-50S (Urine Chemistry system) | DFI Co., Ltd. | 2018-02-16 | 268 | 0 |
| K171083 | iChemVELOCITY Automated Urine Chemistry System | Iris Diagnostics, A Division of Iris International, Inc. | 2017-05-12 | 31 | 0 |
| K160062 | AUTION ELEVEN Semi-Automated Urinalysis System | Arkray, Inc. | 2016-10-07 | 269 | 0 |
| K160372 | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM | Teco Diagnostics, Inc. | 2016-07-22 | 163 | 0 |
| K141289 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDE | Teco Diagnostics | 2015-07-24 | 431 | 0 |
| K131600 | URS-2GP (GLUCOSE PROTEIN) URINE STRIPS | Teco Diagnostics | 2014-05-29 | 360 | 0 |
| K120124 | FORESIGHT U120 URINE ANALYZER | ACON Laboratories, Inc. | 2012-03-06 | 49 | 0 |
| K101673 | URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODEL | Teco Diagnostics | 2011-02-04 | 234 | 0 |
| K091216 | CLINITEK STATUS+ANALYZER AND CLINITEK STATUS CONNECT SYSTEM, | Siemens Healthcare Diagnostics | 2009-10-09 | 165 | 4 |
| K061846 | COMBI SCAN100 | Analyticon Biotechnologies AG | 2007-04-06 | 284 | 0 |
| K061812 | COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 | Analyticon Biotechnologies AG | 2007-04-06 | 284 | 0 |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | Ind Diagnostic, Inc. | 2007-03-01 | 112 | 0 |
| K063276 | CLINITEK ADVANTUS, MODEL 1420 | Bayer Healthcare, LLC | 2006-12-28 | 59 | 0 |
| K061742 | URYXXON RELAX URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | 2006-09-06 | 78 | 0 |
| K060280 | ICHEM 100 URINE CHEMISTRY ANALYZER | Iris International, Inc. | 2006-06-13 | 131 | 0 |
| K052525 | CYBOW 11 SERIES REAGENT STRIPS FOR URINALYSIS | DFI Co., Ltd. | 2006-03-29 | 196 | 0 |
| K051034 | URYXXON 200 URINE ANALYZER | Macherey-Nagel GmbH & Co. KG | 2005-11-22 | 214 | 0 |
| K050801 | URISCAN OPTIMA II URINE ANALYZER | Yd Diagnostics | 2005-04-20 | 21 | 0 |
| K042641 | CHEMVIEW-10 | Cenogenics Corp. | 2005-01-07 | 102 | 0 |
| K033851 | DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK) | Hypoguard USA, Inc. | 2004-03-02 | 82 | 0 |
| K023885 | COMBI-SCREEN, MODELS 10SL AND 11SL | Analyticon Biotechnologies AG | 2003-10-21 | 334 | 0 |
| K032437 | CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS | Roche Diagnostics Corp. | 2003-10-08 | 62 | 0 |
| K022386 | POCKETCHEM UA AUTION STICKS 10TA | Arkray, Inc. | 2002-09-17 | 57 | 0 |
| K020175 | URS-IG (GLUCOSE TEST) | Teco Diagnostics | 2002-03-21 | 63 | 0 |
| K012397 | URISYS 2400 URINE TEST STRIP | Roche Diagnostics Corp. | 2001-09-26 | 61 | 0 |
| K010973 | DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIAS | Hypoguard USA, Inc. | 2001-09-11 | 162 | 0 |
| K991927 | MEDI-TEST COMBI 11 | Macherey-Nagel-Duren | 1999-09-17 | 101 | 1 |
| K973142 | DBEST REAGENT STRIP FOR URINALYSIS | Ameritek, Inc. | 1997-10-20 | 60 | 0 |
| K970250 | CLINISTRIP | Teco Diagnostics | 1997-04-08 | 76 | 0 |
| K954968 | HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST | Tcpi, Inc. | 1996-07-26 | 273 | 0 |
| K961375 | DIA SCREEN 10 WAY REAGENT STRIPS | Genesis Labs, Inc. | 1996-06-18 | 70 | 0 |
| K953661 | FIRST CHOICE GLUCOSE URINE TEST STRIPS | Polymer Technology Intl. | 1996-06-14 | 312 | 0 |
| K952307 | BIOSCAN | Biosys Laboratories, Inc. | 1995-09-05 | 111 | 0 |
| K952971 | DIA SCREEN REAGENT STRIPS | Genesis Labs, Inc. | 1995-08-11 | 45 | 0 |
| K942648 | IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET | Teco Diagnostics | 1995-03-24 | 294 | 0 |
| K946116 | URISTRIP REAGENT STRIPS TEST FOR PROTEIN, GLUCOSE, PH AND BL | Chemtech Labs, Inc. | 1995-03-21 | 96 | 0 |
| K940469 | URINE REAGENT STRIP-3 PARAMETERS | Teco Diagnostics | 1994-09-09 | 219 | 0 |
| K940043 | BIOSCAN REAGENT STRIPS | Bioscan Instruments, Inc. | 1994-04-12 | 97 | 0 |
| K932368 | UROPAPER EIKEN 6B | Tanabe U.S.A., Inc. | 1994-01-13 | 269 | 0 |
| K932366 | UROPAPER EIKEN HAG | Tanabe U.S.A., Inc. | 1993-11-26 | 221 | 0 |
| K932365 | UROPAPER EIKEN AG | Tanabe U.S.A., Inc. | 1993-11-26 | 221 | 0 |
| K932367 | UROPAPER EIKEN 8 | Tanabe U.S.A., Inc. | 1993-11-16 | 211 | 0 |
| K932363 | UROPAPER EIKEN GK | Tanabe U.S.A., Inc. | 1993-11-16 | 211 | 0 |
| K931897 | UROPAPER | Tanabe U.S.A., Inc. | 1993-11-16 | 211 | 0 |
| K932369 | UROPAPER EIKEN 7 | Tanabe U.S.A., Inc. | 1993-11-16 | 211 | 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