Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
CHL · Predicate Candidate Screening
188 FDA 510(k) clearances under this product code; the 50 most recent screened below.
67 daysmedian FDA review time
241 days90th percentile
188clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252207 | ABL90 FLEX PLUS System, safeCLINITUBES | Radiometer Medicals Aps | 2026-04-10 | 270 | 0 |
| K244014 | i-STAT CG4+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2025-05-02 | 127 | 1 |
| K240998 | ABL90 FLEX PLUS System | Radiometer Medicals Aps | 2024-12-13 | 246 | 0 |
| K230285 | i-STAT CG8+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-10-27 | 267 | 0 |
| K221900 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2023-09-29 | 456 | 0 |
| K223857 | i-STAT G3+ cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2023-09-15 | 266 | 1 |
| K223608 | GEM Premier 7000 with IQM3 | Instrumentation Laboratory Company | 2023-08-10 | 251 | 2 |
| K211559 | EasyStat 300 | Medica Corporation | 2023-01-27 | 617 | 0 |
| K203790 | GEM Premier 5000 | Instrumentation Laboratory CO | 2021-08-20 | 235 | 25 |
| K200986 | OPTI® B-Lac Cassette | Opti Medical Systems, Inc. | 2021-08-02 | 474 | 0 |
| K200107 | epoc Blood Analysis System | Epocal, Inc. | 2020-06-05 | 140 | 18 |
| K200492 | i-STAT CG4+ Cartridge with the i-STAT 1 System | Abbott Point of Care, Inc. | 2020-04-09 | 41 | 0 |
| K192240 | RAPIDPoint 500e Blood Gas System | Siemens Healthcare Diagnostics, Inc. | 2020-03-27 | 221 | 2 |
| K193246 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2020-01-24 | 60 | 0 |
| K173797 | Stat Profile Prime Plus Analyzer System | Nova Biomedical Corporation | 2018-07-17 | 215 | 0 |
| K173403 | GEM Premier 5000 | Instrumentation Laboratory CO | 2017-12-29 | 59 | 0 |
| K160412 | GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) | Instrumentation Laboratory CO | 2016-12-14 | 306 | 1 |
| K160153 | ABL90 FLEX PLUS | Radiometer Medical Aps | 2016-11-04 | 287 | 1 |
| K151978 | EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 C | Edan Instruments, Inc. | 2016-07-15 | 364 | 0 |
| K151982 | Stat Profile Prime ABG Analyzer System | Nova Biomedical Corporation | 2015-09-10 | 55 | 0 |
| K151856 | ABL80 FLEX CO-OX with AQURE connectivity | Sendx Medical, Inc. | 2015-08-06 | 29 | 3 |
| K142898 | ABL800 FLEX with AQURE connectivity | Radiometer Medical Aps | 2015-06-17 | 254 | 3 |
| K141907 | STAT PROFILE PRIME CCS ANALYZER SYSTEM, STAT PROFILE PRIME A | Nova Biomedical Corporation | 2015-05-29 | 318 | 0 |
| K142220 | Stat Profile Prime ABG Analyzer System (incl. Controls, Cali | Nova Biomedical Corporation | 2014-10-17 | 66 | 0 |
| K131703 | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM | Nova Biomedical Corporation | 2014-03-25 | 287 | 0 |
| K133407 | GEM PREMIER 4000 | Instrumentation Laboratory CO | 2014-01-13 | 68 | 0 |
| K131988 | ABL90 FLEX ANALYZER | Radiometer Medical Aps | 2013-09-17 | 81 | 0 |
| K131126 | OPTI CCA-TS2 | Opti Medical Systems, Inc. | 2013-08-22 | 122 | 0 |
| K130144 | ABL90 FLEX | Radiometer Medical Aps | 2013-07-31 | 190 | 3 |
| K123748 | ABL90 FLEX | Radiometer Medical Aps | 2013-05-07 | 152 | 0 |
| K122539 | MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM | Siemens Healthcare Diagnostics | 2013-04-19 | 241 | 0 |
| K122729 | ABL90 FLEX | Radiometer Medical Aps | 2012-11-16 | 71 | 0 |
| K122642 | ABL90 FLEX | Radiometer Medical Aps | 2012-10-26 | 58 | 0 |
| K111188 | COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, C | Roche Diagnostics | 2012-05-14 | 383 | 4 |
| K120197 | ABL90 FLEX | Radiometer Medical Aps | 2012-03-19 | 56 | 2 |
| K110648 | NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM | Nova Biomedical Corporation | 2011-08-29 | 178 | 0 |
| K111897 | ABL90 | Radiometer Medical Aps | 2011-07-19 | 14 | 2 |
| K110416 | ABL835 FLEX ANALYZER WITH PLEURAL PH | Radiometer Medical Aps | 2011-03-24 | 38 | 2 |
| K093280 | OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 | Opti Medical Systems, Inc. | 2011-01-07 | 444 | 1 |
| K100777 | ABL837 FLEX ANALYZER | Radiometer Medical Aps | 2010-12-10 | 267 | 2 |
| K080370 | ABL 80 CO-OX SYSTEM | Sendx Medical, Inc. | 2008-07-31 | 170 | 3 |
| K063376 | EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER | Medica Corp. | 2007-06-25 | 229 | 0 |
| K061974 | GEM PREMIER 4000 WITH IQM, MODEL 4000; GEM CVP 1 AND 2 WITH | Instrumentation Laboratory CO | 2006-09-15 | 65 | 4 |
| K051804 | ABL80 FLEX ANALYZER | Sendx Medical, Inc. | 2005-11-01 | 119 | 3 |
| K043218 | ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX | Radiometer Medical Aps | 2005-05-10 | 169 | 3 |
| K050423 | OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) | Roche Diagnostics | 2005-04-22 | 63 | 0 |
| K041874 | ABL800 FLEX | Radiometer Medical Aps | 2004-10-08 | 88 | 12 |
| K031560 | BAYER RAPIDLAB 1200 SYSTEM | Bayer Healthcare, LLC | 2003-12-17 | 212 | 9 |
| K023567 | STAT PROFILE PHOX PLUS L ANALYZER | Nova Biomedical Corp. | 2002-12-20 | 58 | 0 |
| K022746 | STAT PROFILE CRITICAL CARE XPRESS ANALYZER | Nova Biomedical Corp. | 2002-11-22 | 95 | 4 |
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