Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KHS — Predicate Candidate Screening
86 FDA 510(k) clearances under this product code; the 50 most recent screened below.
58 daysmedian FDA review time
212 days90th percentile
86clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170200 | Carbon Dioxide Reagent Set | Teco Diagnostics, Inc. | 2017-06-01 | 129 | 0 |
| K152085 | Liquid CO2-2 (LCO2-2) | Randox Laboratories, Ltd. | 2016-02-24 | 212 | 0 |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | Hitachi Chemical Diagnostics, Inc. | 2014-03-11 | 40 | 0 |
| K131546 | AU BICARBONATE REAGENT | Beckman Coulter Ireland, Inc. | 2013-10-09 | 133 | 4 |
| K123953 | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE | Alfa Wassermann Diagnostic Technologies, Inc. | 2013-05-02 | 132 | 0 |
| K120765 | VITROS CHEMISTRY PRODUCTS ECO2 SLIDES | Ortho-Clinical Diagnostics, Inc. | 2012-10-24 | 225 | 1 |
| K113435 | ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REA | Alfa Wassermann | 2012-07-02 | 224 | 0 |
| K111960 | ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH C | Elitechgroup | 2011-11-18 | 130 | 0 |
| K100060 | EON 100 CHEMISTRY ANALYZER WITH ISE , MODEL 77105, BICARBONA | Vital Diagnostics (Manufacturing) Ptyltd | 2010-12-15 | 338 | 0 |
| K100289 | ADVIA CHEMISTRY SYSTEMS CARBON DIOXIDE LIQUID (C02_L) ASSAY, | Siemens Healthcare Diagnostics | 2010-05-10 | 97 | 0 |
| K093611 | VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY P | Ortho-Clinical Diagnostics, Inc. | 2010-04-15 | 143 | 0 |
| K091153 | SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 | Beckman Coulter, Inc. | 2009-07-13 | 83 | 0 |
| K073223 | S-TEST C02 | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-06-26 | 224 | 0 |
| K071340 | CARBON DIOXIDE (CO2), SCAL, NORTROL AND ABTROL | Thermofisher Scientific OY | 2007-10-05 | 144 | 0 |
| K070251 | CARBON DIOXIDE LIQUID STABLE REAGENT | Pointe Scientific, Inc., | 2007-04-30 | 94 | 0 |
| K060619 | DIAZYME CARBON DIOXIDE ENZYMATIC ASSAY KIT, MODEL KZ122A | Diazyme Laboratories | 2006-07-21 | 135 | 0 |
| K061238 | DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYD | Dade Behring, Inc. | 2006-05-25 | 22 | 1 |
| K060295 | CARBON DIOXIDE | Abbott Laboratories | 2006-05-04 | 87 | 0 |
| K042362 | MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, | Diagnostic Chemicals , Ltd. | 2004-12-27 | 118 | 0 |
| K032377 | ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID | Roche Diagnostics Corp. | 2003-08-21 | 20 | 0 |
| K031879 | COBAS INTEGRA CARBON DIOXIDE ASSAY | Roche Diagnostics Corp. | 2003-07-17 | 29 | 0 |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-09-06 | 45 | 0 |
| K010864 | ANALYST PANELS + ANALYTICAL TEST ROTOR | Hemagen Diagnostics, Inc. | 2001-05-21 | 60 | 0 |
| K010206 | DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF | Dade Behring, Inc. | 2001-03-16 | 52 | 0 |
| K002354 | CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80 | Diagnostic Chemicals , Ltd. | 2000-09-26 | 55 | 0 |
| K001133 | VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2 | Ortho-Clinical Diagnostics, Inc. | 2000-04-24 | 14 | 1 |
| K992475 | CARESIDE CO2, TOTAL | Careside, Inc. | 1999-09-15 | 51 | 0 |
| K991108 | CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 | A.P. Total Care, Inc. | 1999-05-25 | 54 | 0 |
| K990754 | CARBON DIOXIDE - L3K ASSAY, CATALOGUE NUMBER 299-30/40/50 | Diagnostic Chemicals , Ltd. | 1999-04-20 | 43 | 0 |
| K983019 | CARBON DIOXIDE-SL ASSAY, CAT # 253-01 | Diagnostic Chemicals , Ltd. | 1998-09-14 | 14 | 0 |
| K982056 | RAICHEM CO2 REAGENT | Reagents Applications, Inc. | 1998-06-24 | 15 | 0 |
| K981840 | CO2 | Abbott Laboratories | 1998-06-08 | 13 | 0 |
| K980996 | COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE | Roche Diagnostic Systems, Inc. | 1998-06-05 | 80 | 0 |
| K981231 | CO2 | Abbott Mfg., Inc. | 1998-05-12 | 39 | 0 |
| K960035 | CARBON DIOXIDE - DST | Trace America, Inc. | 1996-04-08 | 96 | 0 |
| K960793 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Synermed, Inc. | 1996-03-11 | 13 | 0 |
| K955302 | SERUM BICARBONATE/CARBON DIOXIDE | Data Medical Associates, Inc. | 1996-02-29 | 101 | 0 |
| K951221 | TOTAL CO2 | Randox Laboratories, Ltd. | 1996-02-15 | 332 | 0 |
| K952410 | CARBON DIOXIDE - DST | Trace America, Inc. | 1995-10-05 | 134 | 0 |
| K942735 | CARBON DIOXIDE (C02) | Teco Diagnostics | 1995-03-20 | 283 | 0 |
| K933461 | BOEHRINGER MANNHEIM BICARBONATE ASSAY | Boehringer Mannheim Corp. | 1994-12-05 | 507 | 0 |
| K941156 | TECHNISON AXON SYSTEM | Miles, Inc. | 1994-04-26 | 47 | 0 |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | Intersect Systems, Inc. | 1993-09-24 | 163 | 0 |
| K931887 | BICARBONATE | Em Diagnostic Systems, Inc. | 1993-08-03 | 110 | 0 |
| K924428 | SYNERMED ENZYMATIC CO2 REAGENT KIT | Synermed, Inc. | 1992-12-03 | 93 | 0 |
| K924711 | BICARBONATE | Em Diagnostic Systems, Inc. | 1992-12-03 | 76 | 0 |
| K914486 | COULTER CARBON DIOXIDE REAGENT | Coulter Corp. | 1991-11-27 | 50 | 0 |
| K912806 | ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 | Em Diagnostic Systems, Inc. | 1991-09-11 | 78 | 0 |
| K903409 | SYSTEMATE BICARBONATE OLYMPUS BICARBONATE | Em Diagnostic Systems, Inc. | 1990-10-04 | 65 | 0 |
| K903305 | TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD | Technicon Instruments Corp. | 1990-09-27 | 65 | 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