Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KHE — Predicate Candidate Screening
97 FDA 510(k) clearances under this product code; the 50 most recent screened below.
111 daysmedian FDA review time
243 days90th percentile
97clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173212 | Instant-view-PLUS immunochemical Fecal Occult Blood Test | Alfa Scientific Designs, Inc. | 2018-02-15 | 136 | 0 |
| K170548 | InSure ONE | Enterix, Inc. | 2017-10-05 | 223 | 1 |
| K171484 | hema-screen SPECIFIC Gold | Immunostics Inc., | 2017-06-14 | 23 | 0 |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) Test | Guangzhou Wondfo Biotech Co., Ltd. | 2017-05-14 | 265 | 0 |
| K163554 | hema-screen ER XCEL Enhanced Readability Fecal Occult Blood | Immunostics Inc., | 2017-01-17 | 29 | 0 |
| K143325 | OC-Light S FIT | Eiken Chemical Co., Ltd. | 2015-08-20 | 273 | 0 |
| K121397 | OSOM IFOB 25 TEST AND PATIENT COLLECTION KIT OSOM IFOB CONTR | SEKISUI Diagnostics, LLC | 2012-12-28 | 233 | 0 |
| K113506 | IND ONE STEP OCCULT BLOOD (FOB) TEST | Ind Diagnostics, Inc. | 2012-12-19 | 387 | 0 |
| K110309 | FOB ONE STEP RAPID TEST | Orient Gene Biotech | 2011-09-14 | 224 | 0 |
| K102664 | HEMA SCREEN ER | Immunostics Inc., | 2011-01-28 | 135 | 0 |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | Ind Diagnostic, Inc. | 2010-07-19 | 194 | 0 |
| K100817 | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST | Princeton BioMeditech Corp. | 2010-07-01 | 104 | 0 |
| K080812 | HEMOCCULT ICT | Beckman Coulter, Inc. | 2008-06-25 | 93 | 2 |
| K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS | Ameritek USA, Inc. | 2008-03-06 | 308 | 0 |
| K073431 | FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR | Tianjin New Bay Bioresearch Co., Ltd. | 2008-01-14 | 39 | 2 |
| K070660 | INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST | Alfa Scientific Designs, Inc. | 2007-06-21 | 104 | 0 |
| K063693 | FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST | New Bay Bioresearch Co. , Ltd. | 2007-05-11 | 149 | 4 |
| K063673 | INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE | Innovacon, Inc. | 2007-03-05 | 84 | 0 |
| K060953 | OCCULTECH FECAL OCCULT BLOOD RAPID TEST | Yd Diagnostics Corp. | 2006-09-18 | 165 | 0 |
| K061065 | FECAL OCCULT BLOOD CARD TEST, MODEL F735-A, FECAL OCCULT BLO | Teco Diagnostics | 2006-07-14 | 88 | 0 |
| K060463 | HEMA SCREEN SPECIFIC IFOBT | Immunostics Inc., | 2006-06-06 | 104 | 0 |
| K060930 | INSURE II | Enterix, Inc. | 2006-05-04 | 29 | 1 |
| K052598 | IMMOCARE | Care Diagnostic, Inc. | 2006-03-16 | 176 | 0 |
| K051806 | CARE FECAL OCCULT BLOOD TEST, MODEL KT313 | Epitope Diagnostics, Inc. | 2005-10-03 | 90 | 0 |
| K041297 | POLYMEDCO OC LIGHT FOBT TEST | Polymedco, Inc. | 2004-08-12 | 90 | 1 |
| K041202 | HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST | W.H.P.M., Inc. | 2004-08-12 | 97 | 0 |
| K033548 | ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER | Roche Diagnostics Corp. | 2003-11-24 | 12 | 0 |
| K031356 | HEMAPROMPT GASTRIC | Aerscher Diagnostics | 2003-09-24 | 166 | 0 |
| K030216 | COLONCARE | Care Products, Inc. | 2003-04-02 | 71 | 0 |
| K022755 | LIFEGUARD | Medtek, LLC | 2002-09-24 | 35 | 0 |
| K021423 | INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST | Alfa Scientific Designs, Inc. | 2002-06-17 | 45 | 0 |
| K002756 | EASE-A-CULT | Diagnostica, Inc. | 2001-02-23 | 171 | 0 |
| K002930 | INSTACCULT | Medtek Diagnostics, LLC | 2001-01-22 | 124 | 0 |
| K002457 | !NSURE FECAL OCCULT BLOOD TEST | Enterix, Inc. | 2001-01-12 | 155 | 0 |
| K003359 | COLOSCREEN-ES | Helena Laboratories | 2000-11-27 | 31 | 0 |
| K992759 | COLON ALERT TEST | Immunostics Inc., | 1999-12-06 | 111 | 0 |
| K984269 | DBEST OCCULT BLOOD TEST KIT | Ameritek, Inc. | 1999-05-11 | 201 | 0 |
| K981661 | HEMAPROMPT | Aerscher Diagnostics | 1998-09-15 | 132 | 0 |
| K980671 | COLOSCREEN-ES | Helena Laboratories | 1998-05-12 | 81 | 0 |
| K972763 | HEMAPROMPT | Aerscher Diagnostics | 1997-10-20 | 88 | 0 |
| K961062 | FLEXSURE OBT | Smithkline Diagnostics, Inc. | 1996-11-06 | 233 | 0 |
| K936056 | HEMDETECT(R) TEST FOR OCCULT BLOOD IN FECES | Dipro Diagnostic Products GmbH | 1995-04-05 | 471 | 0 |
| K921798 | PROPPER SUPER SERACULT(R) | Propper Mfg. Co., Inc. | 1992-10-05 | 174 | 0 |
| K913622 | HEMOPLUS | Sarstedt, Inc. | 1992-01-31 | 170 | 0 |
| K912979 | HEMAWIPE SYSTEM, THE CIVILIZED TEST, MODIFICATION | Labeltape Meditect, Inc. | 1991-10-04 | 123 | 0 |
| K905798 | COLOCARE | Helena Laboratories | 1991-07-03 | 226 | 0 |
| K911075 | COLOSCREEN | Helena Laboratories | 1991-07-03 | 114 | 0 |
| K905782 | FHT (FECAL HEME TEST) | Aerscher, Inc. | 1991-05-06 | 136 | 0 |
| K901064 | MONOHAEM (FECAL OCCULT BLOOD TEST) | Silenus Laboratories Proprietary , Ltd. | 1990-11-05 | 243 | 0 |
| K902360 | HEMA-SCREEN | Immunostics Co., Inc. | 1990-07-27 | 59 | 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