| ABL90 FLEX PLUS System, safeCLINITUBES (K252207) | Radiometer Medicals Aps | 2026-04-10 |
| i-STAT CG4+ cartridge with the i-STAT 1 System (K244014) | Abbott Point of Care, Inc. | 2025-05-02 |
| ABL90 FLEX PLUS System (K240998) | Radiometer Medicals Aps | 2024-12-13 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K230285) | Abbott Point of Care, Inc. | 2023-10-27 |
| Stat Profile Prime Plus Analyzer System (K221900) | Nova Biomedical Corporation | 2023-09-29 |
| i-STAT G3+ cartridge with the i-STAT 1 System (K223857) | Abbott Point of Care, Inc. | 2023-09-15 |
| GEM Premier 7000 with IQM3 (K223608) | Instrumentation Laboratory Company | 2023-08-10 |
| EasyStat 300 (K211559) | Medica Corporation | 2023-01-27 |
| GEM Premier 5000 (K203790) | Instrumentation Laboratory CO | 2021-08-20 |
| OPTI® B-Lac Cassette (K200986) | Opti Medical Systems, Inc. | 2021-08-02 |
| epoc Blood Analysis System (K200107) | Epocal, Inc. | 2020-06-05 |
| i-STAT CG4+ Cartridge with the i-STAT 1 System (K200492) | Abbott Point of Care, Inc. | 2020-04-09 |
| RAPIDPoint 500e Blood Gas System (K192240) | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 |
| Stat Profile Prime Plus Analyzer System (K193246) | Nova Biomedical Corporation | 2020-01-24 |
| Stat Profile Prime Plus Analyzer System (K173797) | Nova Biomedical Corporation | 2018-07-17 |
| GEM Premier 5000 (K173403) | Instrumentation Laboratory CO | 2017-12-29 |
| GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) (K160412) | Instrumentation Laboratory CO | 2016-12-14 |
| ABL90 FLEX PLUS (K160153) | Radiometer Medical Aps | 2016-11-04 |
| EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control (K151978) | Edan Instruments, Inc. | 2016-07-15 |
| Stat Profile Prime ABG Analyzer System (K151982) | Nova Biomedical Corporation | 2015-09-10 |
| ABL80 FLEX CO-OX with AQURE connectivity (K151856) | Sendx Medical, Inc. | 2015-08-06 |
| ABL800 FLEX with AQURE connectivity (K142898) | Radiometer Medical Aps | 2015-06-17 |
| STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME AUTO QC CARTRIDGE CCS, STAT PROFILE PRIME AMPULED CONTROL ABG/CCS, STAT PROFILE PRIME CALIBRTOR CARTRIDGE CCS/CCS COMP, NOVA LINEARITY STANDARD SET A (K141907) | Nova Biomedical Corporation | 2015-05-29 |
| Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators) (K142220) | Nova Biomedical Corporation | 2014-10-17 |
| NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM (K131703) | Nova Biomedical Corporation | 2014-03-25 |
| GEM PREMIER 4000 (K133407) | Instrumentation Laboratory CO | 2014-01-13 |
| ABL90 FLEX ANALYZER (K131988) | Radiometer Medical Aps | 2013-09-17 |
| OPTI CCA-TS2 (K131126) | Opti Medical Systems, Inc. | 2013-08-22 |
| ABL90 FLEX (K130144) | Radiometer Medical Aps | 2013-07-31 |
| ABL90 FLEX (K123748) | Radiometer Medical Aps | 2013-05-07 |
| MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM (K122539) | Siemens Healthcare Diagnostics | 2013-04-19 |
| ABL90 FLEX (K122729) | Radiometer Medical Aps | 2012-11-16 |
| ABL90 FLEX (K122642) | Radiometer Medical Aps | 2012-10-26 |
| COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188) | Roche Diagnostics | 2012-05-14 |
| ABL90 FLEX (K120197) | Radiometer Medical Aps | 2012-03-19 |
| NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM (K110648) | Nova Biomedical Corporation | 2011-08-29 |
| ABL90 (K111897) | Radiometer Medical Aps | 2011-07-19 |
| ABL835 FLEX ANALYZER WITH PLEURAL PH (K110416) | Radiometer Medical Aps | 2011-03-24 |
| OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 (K093280) | Opti Medical Systems, Inc. | 2011-01-07 |
| ABL837 FLEX ANALYZER (K100777) | Radiometer Medical Aps | 2010-12-10 |
| ABL 80 CO-OX SYSTEM (K080370) | Sendx Medical, Inc. | 2008-07-31 |
| EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER (K063376) | Medica Corp. | 2007-06-25 |
| GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH CO-OX; GEM CVP 3 AND 4 HEMATOCRIT (K061974) | Instrumentation Laboratory CO | 2006-09-15 |
| ABL80 FLEX ANALYZER (K051804) | Sendx Medical, Inc. | 2005-11-01 |
| ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX (K043218) | Radiometer Medical Aps | 2005-05-10 |
| OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) (K050423) | Roche Diagnostics | 2005-04-22 |
| ABL800 FLEX (K041874) | Radiometer Medical Aps | 2004-10-08 |
| BAYER RAPIDLAB 1200 SYSTEM (K031560) | Bayer Healthcare, LLC | 2003-12-17 |
| STAT PROFILE PHOX PLUS L ANALYZER (K023567) | Nova Biomedical Corp. | 2002-12-20 |
| STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K022746) | Nova Biomedical Corp. | 2002-11-22 |
| STAT PROFILE PHOX PLUS C ANALYZER (K021713) | Nova Biomedical Corp. | 2002-07-25 |
| EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER (K021515) | Medica Corp. | 2002-07-16 |
| STAT PROFILE CRITICAL CARE XPRESS ANALYZER (K020297) | Nova Biomedical Corp. | 2002-06-10 |
| STAT PROFILE PHOX ANALYZER (K014295) | Nova Biomedical Corp. | 2002-02-28 |
| STAT PROFILE PHOX BASIC ANALYZER (K013729) | Nova Biomedical Corp. | 2002-01-15 |
| MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER (K012478) | I-Stat Corp. | 2001-08-20 |
| STAT PROFILE PHOX PLUS L ANALYZER (K012058) | Nova Biomedical Corp. | 2001-08-20 |
| BAYER RAPIDPOINT 400 SYSTEM (K002738) | Bayer Corp. | 2000-12-19 |
| MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER (K002613) | Nova Biomedical Corp. | 2000-10-19 |
| ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) (K002290) | Radiometer Medical A/S | 2000-09-13 |
| AVL OPTI R ANALYZER (K000103) | Avl Scientific Corp. | 2000-03-20 |
| ABL 77 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEM (K994346) | Sendx Medical, Inc. | 2000-02-01 |
| ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE (K992859) | Radiometer America, Inc. | 2000-01-10 |
| CLINICAL BLOOD GAS MIXTURE (K993789) | General Air Service and Supply | 2000-01-10 |
| ABL 735 ANALYZER (K991417) | Radiometer America, Inc. | 1999-11-24 |
| GEM PREMIER 3000 (K992834) | Instrumentation Laboratory CO | 1999-11-24 |
| AVL OMNI MODULAR ANALYZER (K990092) | Avl Scientific Corp. | 1999-01-29 |
| NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM (K982928) | Radiometer America, Inc. | 1999-01-06 |
| 6.8/7.3 BUFFER PACK-MODEL A473-496, WASH SOLUTION PACK-MODEL A73-497 (K984384) | Thermo Bioanalysis Corp. | 1998-12-23 |
| MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) (K982277) | Nova Biomedical Corp. | 1998-07-22 |
| NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) | Nova Biomedical Corp. | 1998-04-15 |
| IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL MULTI-USE CARTRIDGE (K980523) | Diametrics Medical, Inc. | 1998-03-19 |
| ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM (K980130) | Radiometer America, Inc. | 1998-02-09 |
| EASYBLOOD GAS ANALYZER (K974526) | Medica Corp. | 1998-02-05 |
| IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE (K974396) | Diametrics Medical, Inc. | 1997-12-18 |
| ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM (K973367) | Radiometer America, Inc. | 1997-10-06 |
| STAT PROFILE ULTRA M ANALYZER (K970710) | Nova Biomedical Corp. | 1997-05-09 |
| AVL COMPACT 3 PH/BLOOD GAS ANALYZER (K963964) | Avl Scientific Corp. | 1996-11-29 |
| IL SYNTHESIS (K963800) | Instrumentation Laboratory CO | 1996-11-13 |
| GEM PREMIER PLUS MODEL 5500 (K961335) | Mallinckrodt Sensor Systems, Inc. | 1996-06-28 |
| CIBA CORNING 400 SYSTEM (K961657) | Ciba Corning Diagnostics Corp. | 1996-06-25 |
| CIBA CORNING 348 SYSTEM (K962021) | Ciba Corning Diagnostics Corp. | 1996-06-24 |
| AVL OPTI 1 PH/BLOOD GAS ANALYZER (K961161) | Avl Scientific Corp. | 1996-04-26 |
| IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM (K955793) | Instrumentation Laboratory CO | 1996-02-14 |
| SENDX 100 PH, BLOOD GAS & ELECTROLYTE ANALYSIS SYSTEM (K954482) | Cirrus Medical,Inc. | 1995-12-04 |
| STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION) (K954711) | Nova Biomedical Corp. | 1995-11-30 |
| MED-TECH CLINICAL BLOOD GAS (K953935) | Medical Technical Gases Inc.. | 1995-11-20 |
| ABL SYSTEM 625, 615, 605 (K954612) | Radiometer America, Inc. | 1995-11-09 |
| ABL5 BLOOD GAS SYSTEM;BPH5 BLOOD PH SYSTEM (K943882) | Radiometer America, Inc. | 1995-03-10 |
| STAT PROFILE PLUS 10 ANALYZER (K936203) | Nova Biomedical Corp. | 1995-03-09 |
| CIBA CORNING 8-- SERIES CO-OXIMETER (K946206) | Ciba Corning Diagnostics Corp. | 1995-01-30 |
| IRMA BLOOD ANALYSIS SYSTEM (K945240) | Diametrics Medical, Inc. | 1995-01-05 |
| STAT PROFILE ULTRA 11 ANALYZER (K943643) | Nova Biomedical Corp. | 1994-12-29 |
| AVL OPTI PH/BLOOD GAS ANALYZER (K944089) | Avl Scientific Corp. | 1994-10-20 |
| AVL COMPACT 1 PH/BLOOD GAS ANALYZER (K943570) | Avl Scientific Corp. | 1994-08-24 |
| AVL COMPACT 2 PH/BLOOD GAS ANALYZER (K942616) | Avl Scientific Corp. | 1994-07-28 |
| ABL5 BLOOD GAS SYSTEM (K935655) | Radiometer America, Inc. | 1994-05-27 |
| ABL SYSTEM 620 (K935121) | Radiometer America, Inc. | 1994-05-27 |
| I-STAT 200 PORTABLE CLINICAL ANALYZER (K940918) | I-Stat Corp. | 1994-05-10 |
| IL1430 BGELECTROLYTE ANALYZER (K935069) | Instrumentation Laboratory CO | 1994-03-28 |