FDA Product Code CHL: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Leading manufacturers include Nova Biomedical Corp., Fisher Scientific Co., LLC and Instrumentation Laboratory CO.
188
Total
188
Cleared
103d
Avg days
1976
Since
Declining activity -
3 submissions in the last 2 years
vs 5 in the prior period
Review times increasing: avg
214d
recently vs 101d historically
FDA 510(k) Cleared Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph Devices (Product Code CHL)
188 devices
Cleared
Apr 10, 2026
ABL90 FLEX PLUS System, safeCLINITUBES
Radiometer Medicals Aps
Chemistry
270d
Cleared
May 02, 2025
i-STAT CG4+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
127d
Cleared
Dec 13, 2024
ABL90 FLEX PLUS System
Radiometer Medicals Aps
Chemistry
246d
Cleared
Oct 27, 2023
i-STAT CG8+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
267d
Cleared
Sep 29, 2023
Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
Chemistry
456d
Cleared
Sep 15, 2023
i-STAT G3+ cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
266d
Cleared
Aug 10, 2023
GEM Premier 7000 with IQM3
Instrumentation Laboratory Company
Chemistry
251d
Cleared
Jan 27, 2023
EasyStat 300
Medica Corporation
Chemistry
617d
Cleared
Aug 20, 2021
GEM Premier 5000
Instrumentation Laboratory CO
Chemistry
235d
Cleared
Aug 02, 2021
OPTI® B-Lac Cassette
Opti Medical Systems, Inc.
Chemistry
474d
Cleared
Jun 05, 2020
epoc Blood Analysis System
Epocal, Inc.
Chemistry
140d
Cleared
Apr 09, 2020
i-STAT CG4+ Cartridge with the i-STAT 1 System
Abbott Point of Care, Inc.
Chemistry
41d
Cleared
Mar 27, 2020
RAPIDPoint 500e Blood Gas System
Siemens Healthcare Diagnostics, Inc.
Chemistry
221d
Cleared
Jan 24, 2020
Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
Chemistry
60d
Cleared
Jul 17, 2018
Stat Profile Prime Plus Analyzer System
Nova Biomedical Corporation
Chemistry
215d
Cleared
Dec 29, 2017
GEM Premier 5000
Instrumentation Laboratory CO
Chemistry
59d
Cleared
Dec 14, 2016
GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2)
Instrumentation Laboratory CO
Chemistry
306d
Cleared
Jul 15, 2016
EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control
Edan Instruments, Inc.
Chemistry
364d
Cleared
Sep 10, 2015
Stat Profile Prime ABG Analyzer System
Nova Biomedical Corporation
Chemistry
55d
Cleared
May 29, 2015
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
Nova Biomedical Corporation
Chemistry
318d
Cleared
Oct 17, 2014
Stat Profile Prime ABG Analyzer System (incl. Controls, Calibrators)
Nova Biomedical Corporation
Chemistry
66d
Cleared
Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
Nova Biomedical Corporation
Chemistry
287d
Cleared
Jan 13, 2014
GEM PREMIER 4000
Instrumentation Laboratory CO
Chemistry
68d
Cleared
Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
Siemens Healthcare Diagnostics
Chemistry
241d
About Product Code CHL - Regulatory Context
510(k) Submission Activity
188 total 510(k) submissions under product code CHL since 1976, with 188 receiving FDA clearance (average review time: 103 days).
Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 5 in the prior period.
FDA 510(k) Review Time - CHL Product Code
Recent submissions under CHL have taken an average of 214 days to reach a decision - up from 101 days historically. Manufacturers should account for longer review timelines in current project planning.
CHL devices are reviewed by the Chemistry panel. Browse all Chemistry devices →